Native valve repair devices and procedures
Summary by NHIP
Valve repair device with spacer
The device implants a repair apparatus onto native heart valves during non-open-heart procedures. It features a base assembly with pivoting links that move paddles between open and closed positions to attach to leaflets, while a braided mesh, fabric, biocompatible material, foam, or pericardial tissue spacer fills the gap between gripping members.
Claim Score by NHIP
Abstract
A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill at least a portion of a gap between the valve leaflets of the patient.

Term
11.3 yearsleft in the term
Expires 9 January 2038.
- Priority and filed
- Granted
- Today
- Expires
14 claims: 2 independent, 12 dependent
- 1Broadest claimClaim Score 55, average(NHIP)A valve repair device for repairing a native valve of a patient, the valve repair device comprising:a base assembly comprising a plurality of pivoting links and a shaft, wherein the pivoting links are moved by the shaft;a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position;a pair of gripping members attached to the base assembly, wherein the paddles and the gripping members are configured to attach to valve leaflets of the patient;at least one spacer element that surrounds the shaft and is disposed between the pair of gripping members;wherein the spacer element is made from at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial tissue;wherein the spacer element fills a space between the gripping members when the paddles are in the closed position.
- 8A valve repair system for repairing a native valve of a patient during a non-open heart procedure, the valve repair system comprising:a delivery device having at least one lumen;a valve repair device configured to be delivered through the lumen of the delivery device, and configured to attach to a native valve of a patient, the valve repair device comprising: a base assembly comprising a plurality of pivoting links and a shaft, wherein the pivoting links are moved by the shaft;a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position;a pair of gripping members attached to the base assembly, wherein the paddles and the gripping members are configured to attach to valve leaflets of the patient;at least one spacer element that surrounds the shaft and is disposed between the pair of gripping members;wherein the spacer element is made from at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial tissue;wherein the spacer element fills a space between the gripping members when the paddles are in the closed position.
Independent claims2
208 paragraphs in 5 sections, as filed
FIELD OF THE INVENTION
0001The present application relates generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices.
BACKGROUND OF THE INVENTION
0002The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves can result in serious cardiovascular compromise or death. For many years the definitive treatment for such damaged valves was surgical repair or replacement of the valve during open heart surgery. However, open heart surgeries are highly invasive and are prone to many complications. Therefore, elderly and frail patients with defective heart valves often went untreated. More recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery. One particular transvascular technique that is used for accessing the native mitral and aortic valves is the trans-septal technique. The trans septal technique comprises inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium. The septum is then punctured and the catheter passed into the left atrium.
0003A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus can form a “D”-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting free edges of the leaflets when they are closed together.
0004When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as “ventricular diastole” or “diastole”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.
0005Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, dysfunctional papillary muscles and/or stretching of the mitral valve annulus resulting from dilation of the left ventricle. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. For central jet regurgitation, the edges of the leaflets do not meet in the middle. Therefore, the valve does not close and regurgitation is present.
0006Some prior techniques for treating mitral regurgitation in patients include surgically stitching the edges of the native mitral valve leaflets directly to one another. A catheter delivered clip has been used to attempt to clip the edges of the leaflets together like the surgical stitching method. However, this clip has shortcomings, since it can only be used to clip the middle edges of the leaflets where they overlap by 2 mm or more. Alternately, it has been attempted to use multiple clips on the commisures of the mitral valve, where there may be more overlap. This results in a longer operation time and the patient's leaflets are joined at the sides, restricting blood flow. Both the surgical and clip treatments are thought to create stress on patient leaflets.
0007Despite these prior techniques, there is a continuing need for improved devices and methods for treating mitral valve regurgitation.
SUMMARY
0008An exemplary valve repair device for repairing a native valve of a patient includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill a gap between the valve leaflets of the patient.
0009An exemplary valve repair system for repairing a native valve of a patient during a non-open-heart procedure includes a delivery device and a valve repair device. The delivery device has at least one lumen. The valve repair device is configured to be delivered through the lumen of the delivery device and to be attached to a native valve of a patient. The valve repair device includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill a gap between the valve leaflets of the patient.
0010A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.
BRIEF DESCRIPTION OF THE DRAWINGS
To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings.
<figref idref="DRAWINGS">FIG. 1</figref> illustrates a cutaway view of the human heart in a diastolic phase;
<figref idref="DRAWINGS">FIG. 2</figref> illustrates a cutaway view of the human heart in a systolic phase;
<figref idref="DRAWINGS">FIG. 3</figref> illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve;
<figref idref="DRAWINGS">FIG. 4</figref> illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve;
<figref idref="DRAWINGS">FIG. 4A</figref> illustrates tricuspid valve viewed from an atrial side of the tricuspid valve;
<figref idref="DRAWINGS">FIG. 5</figref> illustrates a cutaway view of the human heart in a diastolic phase, in which the chordae tendineae are shown attaching the leaflets of the mitral and tricuspid valves to ventricle walls;
<figref idref="DRAWINGS">FIG. 6</figref> illustrates a valve repair device with paddles in an open position;
<figref idref="DRAWINGS">FIG. 7</figref> illustrates the valve repair device of <figref idref="DRAWINGS">FIG. 6</figref>, in which the paddles are in the open position and gripping members are moved to create a wider gap between the gripping members and paddles;
<figref idref="DRAWINGS">FIG. 8</figref> illustrates the valve repair device of <figref idref="DRAWINGS">FIG. 6</figref>, in which the valve repair device is in the position shown in <figref idref="DRAWINGS">FIG. 7</figref> with valve tissue placed between the gripping members and the paddles;
<figref idref="DRAWINGS">FIG. 9</figref> illustrates the valve repair device of <figref idref="DRAWINGS">FIG. 6</figref>, in which the gripping members are moved to lessen the gap between the gripping members and the paddles;
<figref idref="DRAWINGS">FIGS. 10A-10B</figref> illustrate the movement of the paddles of the valve repair device of <figref idref="DRAWINGS">FIG. 6</figref> from the open position to a closed position;
<figref idref="DRAWINGS">FIG. 11</figref> illustrates the valve repair device of <figref idref="DRAWINGS">FIG. 6</figref> in a closed position, in which the gripping members are engaging valve tissue;
<figref idref="DRAWINGS">FIG. 12</figref> illustrates the valve repair device of <figref idref="DRAWINGS">FIG. 6</figref> after being disconnected from a delivery device and attached to valve tissue, in which the valve repair device is in a closed and locked condition;
<figref idref="DRAWINGS">FIG. 13A</figref> illustrates an exemplary embodiment of a valve repair device attached to the anterior leaflet and the posterior leaflet of a patient's mitral valve, shown from the left atrium of the patient's heart with the valve repair device and leaflet tissue on the ventricular side shown in hidden lines;
<figref idref="DRAWINGS">FIG. 13B</figref> is an enlarged version of <figref idref="DRAWINGS">FIG. 13A</figref>;
<figref idref="DRAWINGS">FIG. 14A</figref> is another exemplary embodiment of a valve repair device attached to the anterior leaflet and the posterior leaflet of a patient's mitral valve with the valve repair device and leaflet tissue on the ventricular side shown in hidden lines;
<figref idref="DRAWINGS">FIG. 14B</figref> is another exemplary embodiment of a valve repair device attached to the anterior leaflet and the posterior leaflet of a patient's mitral valve, in which the valve repair device includes paddles that flex to place less stress on the mitral valve tissue with the valve repair device and leaflet tissue on the ventricular side shown in hidden lines;
<figref idref="DRAWINGS">FIGS. 15A-15B</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes paddles that flex along their length to place less stress on valve tissue when the valve repair device is attached to the valve tissue;
<figref idref="DRAWINGS">FIGS. 16A-16F</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles that comprise an exemplary embodiment of a wire loop;
<figref idref="DRAWINGS">FIGS. 16G-16H</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles that comprise another exemplary embodiment of a wire loop;
<figref idref="DRAWINGS">FIGS. 16I-16J</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles that comprise another exemplary embodiment of a wire loop;
<figref idref="DRAWINGS">FIGS. 17A-17F</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles having a horseshoe shape;
<figref idref="DRAWINGS">FIGS. 18A-18D</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles having a horseshoe shape;
<figref idref="DRAWINGS">FIGS. 18E and 18F</figref> illustrate a compressible paddle that is similar to the compressible paddle shown in <figref idref="DRAWINGS">FIGS. 18C and 18D</figref>, except legs of the paddle do not cross when the paddle is loaded into a catheter;
<figref idref="DRAWINGS">FIGS. 19A-19D</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible mesh paddles;
<figref idref="DRAWINGS">FIGS. 20A-20B</figref> illustrate an exemplary embodiment of a paddle for a valve repair device, in which the paddle is compressible;
<figref idref="DRAWINGS">FIGS. 21A-21B</figref> illustrate another exemplary embodiment of a valve repair device, in which the paddles of the valve repair device are extendable;
<figref idref="DRAWINGS">FIG. 22</figref> illustrates another exemplary embodiment of a valve repair assembly where a gripper control mechanism is configured to control each gripper member of a valve repair device independently;
<figref idref="DRAWINGS">FIGS. 22A-22D</figref> illustrate another exemplary embodiment of a valve repair assembly where an exemplary embodiment of gripper control mechanism is configured to control four gripper members of an exemplary embodiment of valve repair device independently of each other;
<figref idref="DRAWINGS">FIG. 23</figref> illustrates another exemplary embodiment of a valve repair assembly where a gripper control mechanism is configured to control each gripper member of a valve repair device independently;
<figref idref="DRAWINGS">FIG. 24</figref> illustrates an exemplary embodiment of a connection between a placement shaft and a paddle control mechanism shaft of the valve repair device of <figref idref="DRAWINGS">FIG. 23</figref>, in which the gripper control mechanism is attached to the valve repair device at the connection between the placement shaft and the paddle control mechanism shaft;
<figref idref="DRAWINGS">FIGS. 24A-24B</figref> illustrate an exemplary embodiment of a connection between a placement shaft and a paddle control mechanism shaft of the valve repair device of <figref idref="DRAWINGS">FIG. 23</figref>, in which the gripper control mechanism is attached to the valve repair device at the connection between the placement shaft and the shaft of the valve repair device.
<figref idref="DRAWINGS">FIG. 25</figref> illustrates another exemplary embodiment of a valve repair assembly in which a gripper control mechanism is configured to control each gripper member of a valve repair device independently of each other;
<figref idref="DRAWINGS">FIG. 25A</figref> illustrates another exemplary embodiment of a gripper control mechanism that is configured to control each gripper member of a valve repair device independently of each other;
<figref idref="DRAWINGS">FIG. 26</figref> illustrates another exemplary embodiment of a valve repair assembly in which a gripper control mechanism is configured to control each gripper member of a valve repair device independently of each other;
<figref idref="DRAWINGS">FIGS. 27A-27C</figref> illustrate another exemplary embodiment of a valve repair device where each paddle of the valve repair device can be independently moved from an open position to a closed position;
<figref idref="DRAWINGS">FIGS. 28A-28F</figref> illustrate another exemplary embodiment of a valve repair device where each paddle of the valve repair device can be independently moved from an open position to a closed position;
<figref idref="DRAWINGS">FIGS. 29A-29B</figref> illustrate another exemplary embodiment of a valve repair device where each paddle of the valve repair device can be independently moved from an open position to a closed position independent of each other;
<figref idref="DRAWINGS">FIG. 30</figref> illustrates a mitral valve having a wide gap between the posterior leaflet and the anterior leaflet;
<figref idref="DRAWINGS">FIGS. 31A-31B</figref> illustrate another exemplary embodiment of a valve repair device, in which the paddles of the valve repair device expand to create a wide gap for receiving valve tissue;
<figref idref="DRAWINGS">FIGS. 32A-32C</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device is configured such that paddles of the valve repair device expand by pivoting and spreading apart to create a wide gap for receiving valve tissue;
<figref idref="DRAWINGS">FIGS. 33A-33C</figref> illustrate another exemplary embodiment of a valve repair device, in which the valve repair device is configured such that paddles of the valve repair device expand by spreading apart and pivoting to create a wide gap for receiving valve tissue;
<figref idref="DRAWINGS">FIGS. 34A-34B</figref> illustrate another exemplary embodiment of a valve repair device, in which a “W”-shaped mechanism expands the paddles of the valve repair device to create a wide gap;
<figref idref="DRAWINGS">FIGS. 34C-34D</figref> illustrate another exemplary embodiment of a valve repair device, in which a “W”-shaped mechanism expands the paddles of the valve repair device to create a wide gap;
<figref idref="DRAWINGS">FIGS. 35A-35B</figref> illustrate another exemplary embodiment of a valve repair device, in which a “W”-shaped mechanism expands paddles of the valve repair device to create a wide gap for receiving valve tissue;
<figref idref="DRAWINGS">FIGS. 36A-36B</figref> illustrate another exemplary embodiment of a valve repair device, in which a “W”-shaped mechanism expands paddles of the valve repair device to create a wide gap;
<figref idref="DRAWINGS">FIG. 36C</figref> illustrate an exemplary embodiment of a paddle control mechanism for the valve repair device of <figref idref="DRAWINGS">FIGS. 36A-36B</figref>;
<figref idref="DRAWINGS">FIGS. 36D-36E</figref> illustrate another exemplary embodiment of a valve repair device, in which a “W”-shaped mechanism expands paddles of the valve repair device to create a wide gap;
<figref idref="DRAWINGS">FIGS. 37A-37D</figref> illustrate another exemplary embodiment of a valve repair device with mesh paddles and an internal cam for spreading the mesh paddles apart to create a wide gap for spaced apart valve tissues;
<figref idref="DRAWINGS">FIGS. 37E-37F</figref> illustrate another exemplary embodiment of a valve repair device with mesh paddles and an internal cam for spreading the mesh paddles apart to create a wide gap for spaced apart valve tissues;
<figref idref="DRAWINGS">FIG. 38</figref> illustrates an exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element, in which the valve repair device is attached to a mitral valve;
<figref idref="DRAWINGS">FIG. 39</figref> illustrates another exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element, and in which the valve repair device is attached to a mitral valve;
<figref idref="DRAWINGS">FIGS. 40A-40B</figref> illustrate another exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element, in which the spacer element is attached to a shaft of the valve repair device;
<figref idref="DRAWINGS">FIGS. 41A-41D</figref> illustrate another exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element with a first portion attached to a first gripping member of the valve repair device and a second portion attached to a second gripping member of the valve repair device;
<figref idref="DRAWINGS">FIGS. 42A-42C</figref> illustrate the valve repair device of <figref idref="DRAWINGS">FIGS. 40A-40B</figref> with the spacer element having various shapes;
<figref idref="DRAWINGS">FIGS. 43A-43C</figref> illustrate the valve repair device of <figref idref="DRAWINGS">FIGS. 41A-41B</figref> with the spacer element having various shapes;
<figref idref="DRAWINGS">FIGS. 44A-44B</figref> illustrate another exemplary embodiment of a valve repair device with paddles that spread wider and expanding gripping members;
<figref idref="DRAWINGS">FIGS. 45A-45C</figref> illustrate another exemplary embodiment of a valve repair device with an increased bailout angle for removing the valve repair device;
<figref idref="DRAWINGS">FIGS. 46A-46D</figref> illustrate another exemplary embodiment of a valve repair device with an increased bailout angle for removing the valve repair device;
<figref idref="DRAWINGS">FIGS. 47A-47B</figref> illustrate another exemplary embodiment of a valve repair device with an attachment member for connecting the paddles to the grippers when the valve repair device is in a closed position;
<figref idref="DRAWINGS">FIG. 48</figref> illustrates another exemplary embodiment of a valve repair device having a spring member that is configured to bias the paddles of the valve repair device to a closed position;
<figref idref="DRAWINGS">FIG. 49</figref> illustrates another exemplary embodiment of a valve repair device having a threaded mechanism for moving the valve repair device between the open position and the closed position;
<figref idref="DRAWINGS">FIG. 50</figref> illustrates another exemplary embodiment of a valve repair device having gripping members attached to the paddles;
<figref idref="DRAWINGS">FIG. 51</figref> illustrates another exemplary embodiment of a valve repair device having gripping members with a single row of barbs;
<figref idref="DRAWINGS">FIGS. 51A-51E</figref> illustrate another exemplary embodiment of a valve repair system having a valve repair assembly with a valve repair device having gripping members configured to place a tensioning force on valve tissue when the valve repair device is attached to the valve tissue;
<figref idref="DRAWINGS">FIGS. 51F-51H</figref> illustrate another exemplary embodiment of a valve repair assembly having gripping members configured to place a tensioning force on valve tissue when the valve repair device is attached to the valve tissue;
<figref idref="DRAWINGS">FIG. 52</figref> illustrates another exemplary embodiment of a valve repair device having gripping members that are extendable in length;
<figref idref="DRAWINGS">FIGS. 53A-53B</figref> illustrate another exemplary embodiment of a valve repair device having gripping members that are flexible; and
<figref idref="DRAWINGS">FIG. 54</figref> illustrate another exemplary embodiment of a valve repair device, in which gripping members are attached to a separate spring member.
DETAILED DESCRIPTION
0081The following description refers to the accompanying drawings, which illustrate specific embodiments of the invention. Other embodiments having different structures and operation do not depart from the scope of the present invention.
0082Exemplary embodiments of the present disclosure are directed to devices and methods for repairing a defective heart valve. It should be noted that various embodiments of native valve reparation devices and systems for delivery are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.
0083<figref idref="DRAWINGS">FIGS. 1 and 2</figref> are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets <b>302</b>, <b>304</b> shown in <figref idref="DRAWINGS">FIGS. 3 and 4</figref>) extending inward across the respective orifices that come together or “coapt” in the flowstream to form the one-way, fluid-occluding surfaces. The native valve repair systems of the present application are described primarily with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and Left ventricle LV will be explained in greater detail. It should be understood that the devices described herein may also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.
0084The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in <figref idref="DRAWINGS">FIG. 1</figref>, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in <figref idref="DRAWINGS">FIG. 2</figref>, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV and back into the left atrium LA, and blood is collected in the left atrium from the pulmonary vein. In one exemplary embodiment, the devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the devices are configured to help close the leaflets of the mitral valve to prevent blood from regurgitating from the left ventricle LV and back into the left atrium LA.
0085Referring to <figref idref="DRAWINGS">FIGS. 1-5</figref>, the mitral valve MV includes two leaflets, the anterior leaflet <b>302</b> and the posterior leaflet <b>304</b>. The mitral valve MV also includes an annulus <b>306</b>, which is a variably dense fibrous ring of tissues that encircles the leaflets <b>302</b>, <b>304</b>. Referring to <figref idref="DRAWINGS">FIG. 5</figref>, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae <b>501</b>. The chordae tendineae <b>501</b> are cord-like tendons that connect the papillary muscles <b>503</b> (i.e., the muscles located at the base of the chordae tendineae and within the walls of the left ventricle) to the leaflets <b>302</b>, <b>304</b> of the mitral valve MV. The papillary muscles serve to limit the movements of the mitral valve MV and prevent the mitral valve from being reverted. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Rather, the papillary muscles brace the mitral valve MV against the high pressure needed to circulate blood throughout the body. Together the papillary muscles and the chordae tendineae are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes.
0086Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency), inflamatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopaty) can distort a native valve's geometry, which can cause the native valve to dysfunction. However, the vast majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets <b>302</b>, <b>304</b>) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.
0087Generally, a native valve may malfunction in two different ways. One possible malfunction is valve stenosis, which occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow.
0088Another possible malfunction is valve regurgitation, which occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium). There are three mechanisms by which a native valve becomes regurgitant or incompentent, which include Carpentier's type I, type II, and type III malfunctions. A Carpentier type 1 malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as in endocarditis. A Carpentier's type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaption. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or dilation of a ventricle (IIIb).
0089Referring to <figref idref="DRAWINGS">FIG. 3</figref>, when a healthy mitral valve MV is in a closed position, the anterior leaflet <b>302</b> and the posterior leaflet <b>304</b> coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to <figref idref="DRAWINGS">FIG. 4</figref>, regurgitation occurs when the anterior leaflet <b>302</b> and/or the posterior leaflet <b>304</b> of the mitral valve MV is displaced into the left atrium LA during systole. This failure to coapt causes a gap <b>408</b> between the anterior leaflet <b>302</b> and the posterior leaflet <b>304</b>, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole. As set forth above, there are several different ways that a leaflet (e.g. leaflets <b>302</b>, <b>304</b> of mitral valve MV) may malfunction, which can thereby lead to regurgitation.
0090Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating the flow of blood throughout the body, malfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening. Accordingly, because of the substantially higher pressures on the left side of the heart, dysfunction of the mitral valve MV or the aortic valve AV is much more problematic.
0091Malfunctioning native heart valves may either be repaired or replaced. Repair typically involves the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, the most conventional treatments for a stenotic aortic valve or stenotic pulmonary valve are removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets, which, as described above, prevents the mitral valve or tricuspid valve from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae <b>501</b> becoming dysfunctional (e.g., the chordae tendineae may stretch or rupture), which allows the anterior leaflet <b>302</b> and the posterior leaflet <b>304</b> to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae <b>501</b> can be repaired by repairing the chordae tendineae or the structure of the mitral valve (e.g., by securing the leaflets <b>302</b>, <b>304</b> at the affected portion of the mitral valve).
0092The devices and procedures disclosed herein make reference to repairing the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Referring to <figref idref="DRAWINGS">FIG. 4A</figref>, any of the devices and concepts provided herein can be used to repair the tricuspid valve TV. For example, any of the devices and concepts provided herein can be used between any two of the anterior leaflet <b>4011</b>, septal leaflet <b>4012</b>, and posterior leaflet <b>4013</b> to prevent regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets <b>4011</b>, <b>4012</b>, <b>4013</b> together to prevent regurgitation of blood from the right ventricle to the right atrium. That is, the valve repair devices provided herein can be centrally located between the three leaflets <b>4011</b>, <b>4012</b>, <b>4013</b>.
0093<figref idref="DRAWINGS">FIGS. 6-13B</figref> illustrate a valve repair system <b>600</b> for repairing a native valve of a patient. The valve repair system <b>600</b> includes a delivery device <b>601</b> and a valve repair device <b>602</b>, in which delivery device is configured to deliver the valve repair device to the native valve of a patient, and in which the valve repair device is configured to attach to leaflets of a native valve to repair the native valve of the patient. The delivery device <b>601</b> can take any suitable form that is capable of delivering the valve repair device <b>602</b> to the native valve of a patient. In certain embodiments, the valve repair system <b>600</b> is configured to deliver the valve repair device <b>602</b> to a native valve of a patient during a non-open-heart procedure. Suitable delivery means for percutaneously delivering the valve repair system <b>600</b> in a minimal-invasive procedure, can be delivery sleeves or delivery catheters which may be inserted through small incisions in the skin of a patient and advanced to the implantation site, for example along an endovascular (e.g. transfemoral) path or a transapical path.
0094The valve repair device <b>602</b> includes a base assembly <b>604</b>, a pair of paddles <b>606</b>, and a pair of gripping members <b>608</b>. In one exemplary embodiment, the paddles <b>606</b> can be integrally formed with the base assembly. For example, the paddles <b>606</b> can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly <b>604</b> of the valve repair device <b>602</b> has a shaft <b>603</b>, a coupler <b>605</b> configured to move along the shaft, and a lock <b>607</b> configured to lock the coupler in a stationary position on the shaft. The coupler <b>605</b> is mechanically connected to the paddles <b>606</b>, such that movement of the coupler <b>605</b> along the shaft <b>603</b> causes the paddles to move between an open position and a closed position. In this way, the coupler <b>605</b> serves as means for mechanically coupling the paddles <b>606</b> to the shaft <b>603</b> and, when moving along the shaft <b>603</b>, for causing the paddles <b>606</b> to move between their open and closed positions. In certain embodiments, the gripping members <b>608</b> are pivotally connected to the base assembly <b>604</b> (e.g., the gripping members <b>608</b> can be pivotally connected to the shaft <b>603</b>, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening <b>614</b> between the paddles <b>606</b> and the gripping members <b>608</b>. The gripping member <b>608</b> can include a barbed portion <b>609</b> for attaching the gripping members to valve tissue when the valve repair device <b>602</b> is attached to the valve tissue. The gripping member <b>608</b> forms a means for gripping the valve tissue (in particular tissue of the valve leaflets) with a sticking means or portion such as the barbed portion <b>609</b>. When the paddles <b>606</b> are in the closed position, the paddles engage the gripping members <b>608</b>, such that, when valve tissue is attached to the barbed portion <b>609</b> of the gripping members, the paddles act as holding or securing means to hold the valve tissue at the gripping members and to secure the valve repair device <b>602</b> to the valve tissue. In some embodiments, the gripping members <b>608</b> are configured to engage the paddles <b>606</b> such that the barbed portion <b>609</b> engages the valve tissue member and the paddles <b>608</b> to secure the valve repair device <b>602</b> to the valve tissue member. For example, in certain situations, it may be advantageous to have the paddles <b>606</b> maintain an open position and have the gripping members <b>608</b> move outward toward the paddles <b>606</b> to engage a valve tissue member and the paddles <b>606</b>.
0095While the embodiment shown in <figref idref="DRAWINGS">FIGS. 6-13B</figref> illustrate a pair of paddles <b>606</b> and a pair of gripping members <b>608</b>, it should be understood that the valve repair device <b>602</b> can include any suitable number of paddles and gripping members. In certain embodiments, the valve repair system <b>600</b> includes a placement shaft <b>613</b> that is removably attached to the shaft <b>603</b> of the base assembly <b>604</b> of the valve repair device <b>602</b>. After the valve repair device <b>602</b> is secured to valve tissue, the placement shaft <b>613</b> is removed from the shaft <b>603</b> to remove the valve repair device <b>602</b> from the remainder of the valve repair system <b>600</b>, such that the valve repair device <b>602</b> can remain attached to the valve tissue, and the delivery device <b>601</b> can be removed from a patient's body.
0096The valve repair system <b>600</b> can also include a paddle control mechanism <b>610</b>, a gripper control mechanism <b>611</b>, and a lock control mechanism <b>612</b>. The paddle control mechanism <b>610</b> is mechanically attached to the coupler <b>605</b> to move the coupler along the shaft, which causes the paddles <b>606</b> to move between the open and closed positions. The paddle control mechanism <b>610</b> can take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism can comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft <b>613</b> and the shaft <b>603</b> and is connected to the coupler <b>605</b>. The gripper control mechanism <b>611</b> is configured to move the gripping members <b>608</b> such that the width of the opening <b>614</b> between the gripping members and the paddles <b>606</b> can be altered. The gripper control mechanism <b>611</b> can take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.
0097The lock control mechanism <b>612</b> is configured to lock and unlock the lock. The lock <b>607</b> serves as locking means for locking the coupler <b>605</b> in a stationary position with respect to the shaft <b>603</b> and can take a wide variety of different forms and the type of lock control mechanism <b>612</b> may be dictated by the type of lock used. In one embodiment, the lock <b>607</b> takes the form of locks often used in caulk guns. That is, the lock <b>607</b> includes a pivotable plate having a hole, in which the shaft <b>603</b> of the valve repair device <b>602</b> is disposed within the hole of the pivotable plate. In this embodiment, when the pivotable plate is in the tilted position, the pivotable plate engages the shaft <b>603</b> to maintain a position on the shaft <b>603</b>, but, when the pivotable plate is in a substantially non-tilted position, the pivotable plate can be moved along the shaft (which allows the coupler <b>605</b> to move along the shaft <b>603</b>). In other words, the coupler <b>605</b> is prevented from moving in the direction Y (as shown in <figref idref="DRAWINGS">FIG. 10A</figref>) along the shaft <b>603</b> when pivotable plate of the lock <b>607</b> is in a tilted (or locked) position, and the coupler is allowed to move in the direction Y along the shaft <b>603</b> when the pivotable plate is in a substantially non-tilted (or unlocked) position. In embodiments in which the lock <b>607</b> includes a pivotable plate, the lock control mechanism <b>612</b> is configured to engage the pivotable plate to move the plate between the tilted and substantially non-tilted positions. The lock control mechanism <b>612</b> can be, for example, a rod, a suture, a wire, or any other member that is capable of moving a pivotable plate of the lock <b>607</b> between a tilted and substantially non-tilted position. In certain embodiments, the pivotable plate of the lock <b>607</b> is biased in the tilted (or locked) position, and the lock control mechanism <b>612</b> is used to move the plate from the titled position to the substantially non-tilted (or unlocked) position. In other embodiments, the pivotable plate of the lock <b>607</b> is biased in the substantially non-tilted (or unlocked) position, and the lock control mechanism <b>612</b> is used to move the plate from the substantially non-tilted position to the tilted (or locked) position.
0098<figref idref="DRAWINGS">FIGS. 10A-10B</figref> illustrate the valve repair device <b>602</b> moving from an open position (as shown in <figref idref="DRAWINGS">FIG. 10A</figref>) to a closed position (as shown in <figref idref="DRAWINGS">FIG. 10B</figref>). The base assembly <b>604</b> includes a first link <b>1021</b> extending from point A to point B, a second link <b>1022</b> extending from point A to point C, a third link <b>1023</b> extending from point B to point D, a fourth link <b>1024</b> extending from point C to point E, and a fifth link <b>1025</b> extending from point D to point E. The coupler <b>605</b> is movably attached to the shaft <b>603</b>, and the shaft <b>603</b> is fixed to the fifth link <b>1025</b>. The first link <b>1021</b> and the second link <b>1022</b> are pivotally attached to the coupler <b>605</b> at point A, such that movement of the coupler <b>605</b> along the shaft <b>603</b> moves the location of point A and, consequently, moves the first link <b>1021</b> and the second link <b>1022</b>. The first link <b>1021</b> and the third link <b>1023</b> are pivotally attached to each other at point B, and the second link <b>1022</b> and the fourth link <b>1024</b> are pivotally attached to each other at point C. One paddle <b>606</b><i>a </i>is attached to first link <b>1021</b> such that movement of first link <b>1021</b> causes the paddle <b>606</b><i>a </i>to move, and the other paddle <b>606</b><i>b </i>is attached to the second link <b>1022</b> such that movement of the second link <b>1022</b> causes the paddle <b>606</b><i>b </i>to move. Alternatively, the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>can be connected to links <b>1023</b>, <b>1024</b> or be extensions of links <b>1023</b>, <b>1024</b>.
0099In order to move the valve repair device from the open position (as shown in <figref idref="DRAWINGS">FIG. 10A</figref>) to the closed position (as shown in <figref idref="DRAWINGS">FIG. 10B</figref>), the coupler <b>605</b> is moved along the shaft <b>603</b> in the direction Y, which moves the pivot point A for the first links <b>1021</b> and the second link <b>1022</b> to a new position. Movement of the coupler <b>605</b> (and pivot point A) in the direction Y causes a portion of the first link <b>1021</b> near point A to move in the direction H, and the portion of the first link <b>1021</b> near point B to move in the direction J. The paddle <b>606</b><i>a </i>is attached to the first link <b>1021</b> such that movement of the coupler <b>605</b> in the direction Y causes the paddle <b>606</b><i>a </i>to move in the direction Z. In addition, the third link <b>1023</b> is pivotally attached to the first link <b>1021</b> at point B such that movement of the coupler <b>605</b> in the direction Y causes the third link <b>1023</b> to move in the direction K. Similarly, movement of the coupler <b>605</b> (and pivot point A) in the direction Y causes a portion of the second link <b>1022</b> near point A to move in the direction L, and the portion of the second link <b>1022</b> near point C to move in the direction M. The paddle <b>606</b><i>b </i>is attached to the second link <b>1022</b> such that movement of the coupler <b>605</b> in the direction Y causes the paddle <b>606</b><i>b </i>to move in the direction V. In addition, the fourth link <b>1024</b> is pivotally attached to the second link <b>1022</b> at point C such that movement of the coupler <b>605</b> in the direction Y causes the fourth link <b>1024</b> to move in the direction N. <figref idref="DRAWINGS">FIG. 10B</figref> illustrates the final position of the valve repair device <b>602</b> after the coupler <b>605</b> is moved as shown in <figref idref="DRAWINGS">FIG. 10A</figref>.
0100Referring to <figref idref="DRAWINGS">FIG. 7</figref>, the valve repair device <b>602</b> is shown in the open position (similar to the position shown in <figref idref="DRAWINGS">FIG. 10A</figref>), and the gripper control mechanism <b>611</b> is shown moving the gripping members <b>608</b> to provide a wider gap at the opening <b>614</b> between the gripping members and the paddles <b>606</b>. In the illustrated embodiment, the gripper control mechanism <b>611</b> includes a line, such as a suture, a wire, etc. that is threaded through an opening in an end of the gripper members <b>608</b>. Both ends of the line extending through the delivery opening <b>716</b> of the delivery device <b>601</b>. When the line is pulled through the delivery opening <b>716</b> in the direction Y, the gripping members <b>608</b> move inward in the direction X, which causes the opening <b>614</b> between the gripping members and the paddles <b>606</b> to become wider.
0101Referring to <figref idref="DRAWINGS">FIG. 8</figref>, the valve repair device <b>602</b> is shown such that valve tissue <b>820</b> is disposed in the opening <b>614</b> between the gripping members <b>608</b> and the paddles <b>606</b>. Referring to <figref idref="DRAWINGS">FIG. 9</figref>, after the valve tissue <b>820</b> is disposed between the gripping members <b>608</b> and the paddles <b>606</b>, the gripper control mechanism <b>611</b> is used to lessen the width of the opening <b>614</b> between the gripping members and the paddles. That is, in the illustrated embodiment, the line of the gripper control mechanism <b>611</b> is released from or pushed out of the opening <b>716</b> of the delivery member in the direction H, which allows the gripping members <b>608</b> to move in the direction D to lessen the width of the opening <b>614</b>. While the gripper control mechanism <b>611</b> is shown moving the gripping members <b>608</b> to increase the width of the opening <b>614</b> between the gripping members and the paddles <b>606</b> (<figref idref="DRAWINGS">FIG. 8</figref>), it should be understood that the gripping members may not need to be moved in order to position valve tissue in the opening <b>614</b>. In certain circumstances, however, the opening <b>614</b> between the paddles <b>606</b> and the gripping members <b>608</b> may need to be wider in order to receive the valve tissue.
0102Referring to <figref idref="DRAWINGS">FIG. 11</figref>, the valve repair device <b>602</b> is in the closed position and secured to valve tissue <b>820</b>. The valve repair device <b>602</b> is secured to the valve tissue <b>820</b> by the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>and the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>. In particular, the valve tissue <b>820</b> is attached to the valve repair device <b>602</b> by the barbed portion <b>609</b> of the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>, and the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>engage the gripping members <b>608</b> to secure the valve repair device <b>602</b> to the valve tissue <b>820</b>. In order to move the valve repair device <b>602</b> from the open position to the closed position, the lock <b>607</b> is moved to an unlocked condition (as shown in <figref idref="DRAWINGS">FIG. 11</figref>) by the lock control mechanism <b>612</b>. Once the lock <b>607</b> is in the unlocked condition, the coupler <b>605</b> can be moved along the shaft <b>603</b> by the paddle control mechanism <b>610</b>. In the illustrated embodiment, the paddle control mechanism <b>610</b> moves the coupler <b>605</b> in a direction Y along the shaft, which causes one paddle <b>606</b><i>a </i>to move in a direct X and the other paddle <b>606</b><i>b </i>to move in a direction Z. The movement of the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>in the direction X and the direction Z, causes the paddles to engage the gripping members <b>608</b><i>a</i>, <b>608</b><i>b </i>and secure the valve repair device <b>602</b> to the valve tissue <b>820</b>.
0103Referring to <figref idref="DRAWINGS">FIG. 12</figref>, after the paddles <b>606</b> are moved to the closed position to secure the valve repair device <b>602</b> to the valve tissue <b>820</b> (as shown in <figref idref="DRAWINGS">FIG. 11</figref>), the lock <b>607</b> is moved to the locked condition by the locking control mechanism <b>611</b> (<figref idref="DRAWINGS">FIG. 11</figref>) to maintain the valve repair device <b>602</b> in the closed position. After the valve repair device <b>602</b> is maintained in the locked condition by the lock <b>607</b>, the valve repair device <b>602</b> is removed from the delivery device <b>601</b> by disconnecting the shaft <b>603</b> from the placement shaft <b>613</b> (<figref idref="DRAWINGS">FIG. 11</figref>). In addition, the valve repair device <b>602</b> is disengaged from the paddle control mechanism <b>610</b> (<figref idref="DRAWINGS">FIG. 11</figref>), the gripper control mechanism <b>611</b> (<figref idref="DRAWINGS">FIG. 11</figref>), and the lock control mechanism <b>612</b>. Removal of the valve repair device <b>602</b> from the delivery device <b>601</b> allows the valve repair device to remain secured to valve tissue <b>820</b> while the delivery device <b>601</b> is removed from a patient.
0104Referring to <figref idref="DRAWINGS">FIGS. 13A-13B</figref>, the mitral valve <b>1300</b> of a patient is shown with a valve repair device <b>602</b> attached to the anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b> of the mitral valve. <figref idref="DRAWINGS">FIGS. 13A-13B</figref> are views from the atrial side of the mitral valve <b>1300</b> with portions of the valve repair device <b>602</b> and captured mitral valve leaflet tissue on the ventricular side of the mitral valve depicted in hidden lines. During the diastolic phase (as shown in <figref idref="DRAWINGS">FIG. 1</figref>), the blood that collects in the left atrium of the heart enters the mitral valve <b>1300</b> by expansion of the left ventricle of the heart. The anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b> open to allow blood to travel from the left atrium to the left ventricle. In the systolic phase (as shown in <figref idref="DRAWINGS">FIG. 2</figref>), the left ventricle contracts to force the blood through the aortic valve and the ascending aorta and into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating back into the left atrium LA. As described above, regurgitation of blood from the left ventricle to the left atrium through the mitral valve occurs when the anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b> do not close entirely such that a gap exists between the anterior leaflet and the posterior leaflet. In order to repair a mitral valve <b>1300</b> to prevent regurgitation of blood through the mitral valve, the valve repair device <b>602</b> is connected to the anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b> to close the gap.
0105Referring to <figref idref="DRAWINGS">FIG. 13A</figref>, the mitral valve <b>1300</b> is shown from the left atrium of a patient's heart (e.g., from the view indicated by line A-A in <figref idref="DRAWINGS">FIG. 5</figref>). In the illustrated embodiment, the mitral valve <b>1300</b> is shown in an open position (i.e., the position the mitral valve takes during the diastolic phase). The valve repair device <b>602</b> is attached to the anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b> of the mitral valve <b>1300</b> in the left ventricle of the patient's heart, and is shown in dotted lines in <figref idref="DRAWINGS">FIGS. 13A-13B</figref> to indicate the location of the valve repair device with respect to the mitral valve. As shown in <figref idref="DRAWINGS">FIGS. 13A-13B</figref>, the valve repair device <b>602</b> engages the anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b> and causes the anterior leaflet and posterior leaflet to engage each other (i.e., the valve repair device closes a portion of the gap between the anterior leaflet and the posterior leaflet). The valve repair device <b>602</b> can be placed in a location in which a gap exists between the anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b> when the mitral valve <b>1301</b> is in a closed position (i.e., the position of the mitral valve during the systolic phase), such that the valve repair device will prevent the gap from occurring. The illustrated embodiment shows the mitral valve <b>1300</b> and valve repair device <b>602</b> during the diastolic phase. That is, during the diastolic phase, the valve repair device <b>602</b> will cause a portion of the mitral valve to remain closed, but the portions of the mitral valve not engaged by the valve repair device will open such that gaps <b>1303</b> are created to allow blood to flow from the left atrium to the left ventricle.
0106Referring to <figref idref="DRAWINGS">FIG. 13B</figref>, the valve repair device <b>602</b> is attached to both the anterior leaflet <b>1301</b> and the posterior leaflet <b>1302</b>. In particular, a portion <b>1301</b><i>a </i>of the anterior leaflet <b>1301</b> is secured between a paddle <b>606</b><i>a </i>and a gripping member <b>608</b><i>a </i>of the valve repair device <b>602</b>, and a portion <b>1302</b><i>b </i>of the posterior leaflet <b>1302</b> is secured between another paddle <b>606</b><i>b </i>and another gripping member <b>608</b><i>b </i>of the valve repair device. The valve repair device <b>602</b> is secured and locked to the mitral valve <b>1300</b>, for example, as shown in <figref idref="DRAWINGS">FIGS. 6-12</figref>.
0107<figref idref="DRAWINGS">FIGS. 14A-14B</figref> illustrate exemplary embodiments of a valve repair device <b>602</b> attached to the anterior leaflet <b>1301</b> and posterior leaflet <b>1302</b> of a mitral valve <b>1300</b>. The mitral valve <b>1300</b> is shown from the left atrium of a patient's heart (e.g., from the view indicated by line A-A in <figref idref="DRAWINGS">FIG. 5</figref>). Still referring to <figref idref="DRAWINGS">FIGS. 14A-14B</figref>, the valve repair device <b>602</b> includes a first paddle <b>606</b><i>a</i>, a second paddle <b>606</b><i>b</i>, a first gripping member <b>608</b><i>a</i>, and a second gripping member <b>608</b><i>b</i>. A portion <b>1301</b><i>a </i>of the anterior leaflet <b>1301</b> is secured between the first paddle <b>606</b><i>a </i>and the first gripping member <b>608</b><i>a </i>of the valve repair device <b>602</b>, and a portion <b>1302</b><i>b </i>of the posterior leaflet <b>1302</b> is secured between the second paddle <b>606</b><i>b </i>and the second gripping member <b>608</b><i>b </i>of the valve repair device. The first and second paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>include a main portion <b>1404</b> and side portions <b>1405</b>. Referring to <figref idref="DRAWINGS">FIG. 14A</figref>, the valve repair device <b>602</b> is configured such that the portions <b>1301</b><i>a</i>, <b>1302</b><i>b </i>of the mitral valve <b>1300</b> conform to or generally conform to the shape of the paddles <b>606</b><i>a</i>, <b>606</b><i>b</i>. That is, the valve leaflet portions <b>1301</b><i>a</i>, <b>1302</b><i>b </i>are pressed into the paddles by the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>, such that the valve leaflet portions <b>1301</b><i>a</i>, <b>1301</b><i>b </i>are disposed along a main portion <b>1404</b> and side portions <b>1405</b> of the paddles <b>606</b><i>a</i>, <b>606</b><i>b</i>. In the embodiment of the valve repair device <b>602</b> shown in <figref idref="DRAWINGS">FIG. 14A</figref>, the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>can be made of a rigid material, for example, steel, molded plastic, etc.
0108In the exemplary embodiment illustrated by <figref idref="DRAWINGS">FIG. 14B</figref>, the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>of the valve repair device <b>602</b> are configured to flex. Because of this flex, when the valve repair device is attached to the mitral valve <b>1300</b>, the mitral valve tissue portions <b>1301</b><i>a</i>, <b>1302</b><i>b </i>move the side portions <b>1405</b> of the paddles as indicated by arrows <b>1450</b>, which reduces the stress placed on the mitral valve by the valve repair device as compared to the embodiment illustrated by <figref idref="DRAWINGS">FIG. 14A</figref>. That is, the flexing results in a more gradual contouring of the mitral valve tissue by the paddles, while still securely attaching the valve repair device <b>602</b> to the mitral valve tissue. In the embodiment of the valve repair device <b>602</b> shown in <figref idref="DRAWINGS">FIG. 14B</figref>, the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>can be made of a wide variety of different flexible materials or rigid materials that are cut or otherwise processed to provide flexibility.
0109<figref idref="DRAWINGS">FIGS. 15A-15B</figref> illustrate another exemplary embodiment of a valve repair device <b>602</b>. Referring to <figref idref="DRAWINGS">FIG. 15A</figref>, the valve repair device <b>602</b> is in the open position and about to engage valve tissue <b>820</b> (e.g., the leaflets of a mitral valve). Referring to <figref idref="DRAWINGS">FIG. 15B</figref>, the valve repair device <b>602</b> is in the closed position and secured to the valve tissue <b>820</b>. The valve repair device <b>602</b> can take any suitable form, such as, for example, any form described in the present application. The valve repair device <b>602</b> can be moved between the open and closed position, and be attached to the valve tissue <b>820</b>, by a valve repair system, such as, for example, any valve repair system described in the present application. In the illustrated embodiment, the valve repair device <b>602</b> includes paddles <b>606</b> and gripping members <b>608</b>. The gripping members <b>608</b> include a barbed portion <b>609</b> for attaching the gripping members to valve tissue <b>820</b>. Referring to <figref idref="DRAWINGS">FIG. 15A</figref>, when the valve repair device <b>602</b> is in the open position, the paddles <b>606</b> maintain an original form. Referring to <figref idref="DRAWINGS">FIG. 15B</figref>, upon engagement with the valve tissue <b>820</b>, the paddles <b>606</b> flex along their length L. That is, a portion of the paddles <b>606</b> flex in an inward direction X, and another portion of the paddles extend in an outward direction Z. This flexing of the paddles <b>606</b> allows the paddles to conform to the shape of the valve tissue, which places less stress on the valve tissue.
0110Referring to <figref idref="DRAWINGS">FIGS. 16A-16F</figref>, another exemplary embodiment of a valve repair device <b>602</b> includes paddles <b>606</b> having a wire loop <b>1601</b>. The wire loop <b>1601</b> can be made of, for example, any suitable metal material, laser cut loops from a sheet of nitinol, a tube of nitinol, or any other suitable material. In some embodiments, the wire loop <b>1601</b> can have varying dimensions throughout the length of the wire loop <b>1601</b> to optimize the paddle pinch force and the paddle crimp force on a valve tissue when paddle engages the valve tissue. For example, certain sections of the wire loop <b>1601</b> can be thinner than other sections of the wire loop <b>1601</b>. In certain embodiments, the wire loop <b>1601</b> of the paddles <b>606</b> is compressible, which allows the paddles <b>606</b> to be disposed in a delivery device <b>601</b> (e.g., a catheter) that has a small diameter (as shown in <figref idref="DRAWINGS">FIG. 16E</figref>) for delivery of the valve repair device <b>602</b> to a native valve of a patient, and also allows the paddles <b>606</b> to expand (as shown in <figref idref="DRAWINGS">FIGS. 16A-16D</figref>) upon exiting the delivery device <b>601</b> such that the paddles <b>606</b> have a larger surface area for engaging the native valve of the patient. The valve repair device <b>602</b> can take any suitable form, such as, for example, any form described in the present application. The valve repair device <b>602</b> can be moved between the open and closed position, and be attached to a native valve, by a valve repair system, such as, for example, any valve repair system described in the present application.
0111<figref idref="DRAWINGS">FIGS. 16A-16B</figref> illustrate the valve repair device <b>602</b> in the open position, and <figref idref="DRAWINGS">FIGS. 16C-16D</figref> illustrate the valve repair device in the closed position. Referring to <figref idref="DRAWINGS">FIGS. 16A-16B</figref>, when the valve repair device <b>602</b> is in the expanded and open position, the paddles <b>606</b> extend outward to create wide opening <b>614</b> between the paddles <b>606</b> and gripping members <b>608</b> of the valve repair device <b>602</b>. Referring to <figref idref="DRAWINGS">FIGS. 16C-16D</figref>, when the valve repair device <b>602</b> is in the expanded and closed position, the paddles <b>606</b> engage the gripping members <b>608</b> such that valve tissue can be secured between the paddles and the gripping members. The paddles <b>606</b> include a curved surface <b>1603</b>, which is configured to place less stress on valve tissue when the valve repair device <b>602</b> is attached to the valve tissue. When the paddles <b>606</b> are in the expanded condition, the paddles have a width W. The width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, the width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W can be less than 5 mm. In certain embodiments, the paddles <b>606</b> include a material <b>1605</b> disposed over the wire loop <b>1601</b> for creating a contact area for the paddles to engage valve tissue. The material <b>1605</b> can be any suitable material, such as, for example, a woven material, an electrospun material, or any other material that is capable of promoting tissue ingrowth and protecting liners of the delivery device <b>601</b> (<figref idref="DRAWINGS">FIG. 6</figref>) during tracking. In certain embodiments, the material <b>1605</b> can be a blood-impermeable cloth, such as a PET cloth or biocompatible covering material such as a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.
0112Referring to <figref idref="DRAWINGS">FIG. 16E</figref>, the paddles <b>606</b> are in a compressed condition when the paddles are disposed in a delivery device <b>601</b>. When the paddles <b>606</b> are in the compressed condition, the paddles have a width H. The width H can be, for example between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles <b>606</b> is substantially equal to a width D of the delivery opening <b>716</b> of the delivery device <b>601</b>. The ratio between the width W of the paddles in the expanded condition and the width H of the paddles in the compressed condition can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In alternative embodiments, the ratio between the width W and the width H can be more than 4 to 1. Referring to <figref idref="DRAWINGS">FIG. 16F</figref>, a paddle <b>606</b> is moved from the expanded condition to the compressed condition by compressing the paddle in the direction Y and extending a length of the paddle in the direction X.
0113<figref idref="DRAWINGS">FIGS. 16G-16H</figref> illustrate another exemplary embodiment of a valve repair device <b>602</b> in the open position, in which the valve repair device includes paddles <b>606</b> having a wire loop <b>1601</b>. In the illustrated embodiment, the paddles <b>606</b> are shown having a wire loop <b>1601</b> that includes three lobes <b>1611</b>. Referring to <figref idref="DRAWINGS">FIGS. 16I-16J</figref>, another exemplary embodiment of a valve repair device <b>602</b> includes paddles <b>606</b> having a wire loop <b>1601</b> with two lobes <b>1611</b>. While the embodiments shown in <figref idref="DRAWINGS">FIGS. 16G-16H and 16I-16J</figref> show the wire loop <b>1601</b> of the paddles <b>606</b> having three lobes and two lobes, respectively, it should be understood that the valve repair device <b>602</b> can include paddles <b>606</b> with a wire loop <b>1601</b> having any suitable number of lobes <b>1611</b>, such as, for example, two or more lobes, three or more lobes, four or more lobes, five or more lobes, etc. A paddle <b>606</b> having a wire loop <b>1601</b> having lobes is advantageous because a paddle having lobes can more easily allow chordae tendinae to assume their natural positions than a single wire loop having no lobes. That is, the chordae tendinae can move into spaces between the multiple of loops.
0114The embodiments of the valve repair devices <b>602</b> shown in <figref idref="DRAWINGS">FIGS. 16G-16H and 16I-16J</figref> can include any of the features described above with reference to <figref idref="DRAWINGS">FIGS. 16A-16F</figref>. For example, the embodiments of the valve repair devices <b>602</b> shown in <figref idref="DRAWINGS">FIGS. 16G-16H and 16I-16J</figref> can include a width W, in which the width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, the width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W can be less than 5 mm. The embodiments for the paddles <b>606</b> shown in <figref idref="DRAWINGS">FIGS. 16G-16H and 16I-16J</figref> can also include a material disposed over the wire loop <b>1601</b> for creating a contact area for the paddles to engage valve tissue. The material can be any suitable material, such as, for example, a woven material, an electrospun material, or any other suitable material that is capable of promoting tissue ingrowth and protecting liners of the delivery device <b>601</b> (<figref idref="DRAWINGS">FIG. 6</figref>) during tracking. In certain embodiments, the material <b>1605</b> can be a blood-impermeable cloth, such as a PET cloth or biocompatible covering material such as a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium. The embodiments for the paddles <b>606</b> shown in <figref idref="DRAWINGS">FIGS. 16G-16H and 16I-16J</figref> can also be compressed when disposed in a delivery device <b>601</b> (e.g., just as shown in <figref idref="DRAWINGS">FIG. 16E</figref> with respect to the embodiment of the paddles <b>606</b> shown in <figref idref="DRAWINGS">FIGS. 16A-16B</figref>). The ratio between the width W of the paddles <b>606</b> in the expanded condition and the width of the paddles in the compressed condition can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In alternative embodiments, the ratio between the width W and the width H can be more than 4 to 1.
0115Referring to <figref idref="DRAWINGS">FIGS. 17A-17F</figref>, another exemplary embodiment of a valve repair device <b>602</b> includes paddles <b>606</b> having a horseshoe shape <b>1701</b>. In certain embodiments, the horseshoe shape <b>1701</b> of the paddles <b>606</b> is compressible, which allows the paddles <b>606</b> to be disposed in a delivery device <b>601</b> (e.g., a catheter) that has a small diameter (as shown in <figref idref="DRAWINGS">FIG. 17F</figref>) for delivery of the valve repair device <b>602</b> to a native valve of a patient, and also allows the paddles <b>606</b> to expand (as shown in <figref idref="DRAWINGS">FIGS. 17A-17D</figref>) upon exiting the delivery device <b>601</b> such that the paddles <b>606</b> have a larger surface area for engaging the native valve of the patient. The valve repair device <b>602</b> can take any suitable form, such as, for example, any form described in the present application. The valve repair device <b>602</b> can be moved between the open and closed position, and be attached to a native valve, by a valve repair system, such as, for example, any valve repair system described in the present application.
0116<figref idref="DRAWINGS">FIGS. 17A-17C</figref> illustrate the valve repair device <b>602</b> in the open position. Referring to <figref idref="DRAWINGS">FIGS. 17A-17B</figref>, when the valve repair device <b>602</b> is in the expanded and open position, the paddles <b>606</b> extend outward to create wide opening <b>614</b> between the paddles <b>606</b> and gripping members <b>608</b> of the valve repair device <b>602</b>. In the illustrated embodiment, the horseshoe shape <b>1701</b> of the paddles <b>606</b> includes side members <b>1707</b> that extend from a base <b>1706</b> of the paddle <b>606</b>, and a center member <b>1709</b> that extends from the base <b>1706</b> and connects to a base assembly <b>604</b> of the valve repair device <b>602</b>, in which the side members <b>1707</b> form a horseshoe shape as shown in <figref idref="DRAWINGS">FIG. 17C</figref>, for example. In certain embodiments, the paddles <b>606</b> include a material <b>1705</b> disposed over the horseshoe shape <b>1701</b> for creating a contact area for the paddles to engage valve tissue. The material <b>1705</b> can be any suitable material, such as, for example, a woven material, an electrospun material, or any other material that is capable of promoting tissue ingrowth and protecting liners of the delivery device <b>601</b> (<figref idref="DRAWINGS">FIG. 6</figref>) during tracking. In certain embodiments, the material <b>1605</b> can be a blood-impermeable cloth, such as a PET cloth or biocompatible covering material such as a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.
0117In various embodiments, the paddles <b>606</b> are configured to flex to place less stress on valve tissue when the valve repair device <b>602</b> is attached to the valve tissue. When the paddles <b>606</b> are in the expanded condition, the paddles have a width W. The width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, the width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W can be less than 5 mm. Referring to <figref idref="DRAWINGS">FIG. 17D</figref>, in certain embodiments, the thickness T of the paddle is, for example, between about 0.3 mm and about 0.46 mm, such as between about 0.32 mm and about 0.44 mm, such as between about 0.34 mm and about 0.42 mm, such as between about 0.36 mm and about 0.40 mm, such as about 0.38 mm. In alternative embodiments, the thickness T of the paddle can be less than 0.3 mm or more than 0.46 mm.
0118Referring to <figref idref="DRAWINGS">FIG. 17E</figref>, the paddles <b>606</b> are in a compressed condition when the paddles are disposed in a delivery device <b>601</b>. When the paddles <b>606</b> are in the compressed condition, the paddles have a width H. The width H can be, for example between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles <b>606</b> is equal to a width D of the delivery opening <b>716</b> of the delivery device <b>601</b>. The ratio between the width W of the paddles in the expanded condition and the width H of the paddles in the compressed condition can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In alternative embodiments, the ratio between the width W and the width H can be more than 4 to 1. Referring to <figref idref="DRAWINGS">FIG. 17F</figref>, a paddle <b>606</b> is moved from the expanded condition to the compressed condition by compressing the paddle in the direction Y and extending a length of the paddle in the direction X. In the illustrated embodiment, the length of the side members <b>1707</b> of the paddle <b>606</b> are extended when the paddle is in the compressed condition, but the length of the center member <b>1709</b> maintains the same length.
0119Referring to <figref idref="DRAWINGS">FIGS. 18A-18D</figref>, another exemplary embodiment of a valve repair device <b>602</b> includes paddles <b>606</b> having another horseshoe shape <b>1801</b>. In certain embodiments, the horseshoe shape <b>1801</b> of the paddles <b>606</b> is compressible, which allows the paddles <b>606</b> to be disposed in a delivery device <b>601</b> (e.g., a catheter) that has a small diameter (as shown in <figref idref="DRAWINGS">FIG. 18C</figref>) for delivery of the valve repair device <b>602</b> to a native valve of a patient, and also allows the paddles <b>606</b> to expand (as shown in <figref idref="DRAWINGS">FIGS. 18A-18B</figref>) upon exiting the delivery device <b>601</b> such that the paddles <b>606</b> have a larger surface area for engaging the native valve of the patient. The valve repair device <b>602</b> can take any suitable form, such as, for example, any form described in the present application. The valve repair device <b>602</b> can be moved between the open and closed position, and be attached to a native valve, by a valve repair system, such as, for example, any valve repair system described in the present application.
0120<figref idref="DRAWINGS">FIGS. 18A-18B</figref> illustrate the valve repair device <b>602</b> in the open position. When the valve repair device <b>602</b> is in the open position, the paddles <b>606</b> extend outward to create wide opening <b>614</b> between the paddles <b>606</b> and gripping members <b>608</b> of the valve repair device <b>602</b>. In the illustrated embodiment, the horseshoe shape <b>1801</b> of the paddles <b>606</b> includes side members <b>1807</b> that extend from a base <b>1806</b> of the paddle <b>606</b>, and the base <b>1806</b> is attached to the base assembly <b>604</b> of the valve repair device <b>602</b>. In certain embodiments, the paddles <b>606</b> include a material <b>1805</b> disposed over the horseshoe shape <b>1801</b> for creating a contact area for the paddles to engage valve tissue. The material <b>1805</b> can be any suitable material, such as, for example, a woven material, an electrospun material, or any other material that is capable of promoting tissue ingrowth and protecting liners of the delivery device <b>601</b> (<figref idref="DRAWINGS">FIG. 6</figref>) during tracking. In certain embodiments, the material <b>1605</b> can be a blood-impermeable cloth, such as a PET cloth or biocompatible covering material such as a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.
0121In various embodiments, the paddles <b>606</b> are configured to flex to place less stress on valve tissue when the valve repair device <b>602</b> is attached to the valve tissue. When the paddles <b>606</b> are in the expanded condition, the paddles have a width W. The width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, the width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W can be less than 5 mm.
0122Referring to <figref idref="DRAWINGS">FIG. 18C</figref>, the paddles <b>606</b> are in a compressed condition when the paddles are disposed in a delivery device <b>601</b>. When the paddles <b>606</b> are in the compressed condition, the paddles have a width H. The width H can be, for example between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles <b>606</b> is equal to a width D of the delivery opening <b>716</b> of the delivery device <b>601</b>. The ratio between the width W of the paddles in the expanded condition and the width H of the paddles in the compressed condition can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In alternative embodiments, the ratio between the width W and the width H can be more than 4 to 1. Referring to <figref idref="DRAWINGS">FIG. 18D</figref>, a paddle <b>606</b> is moved from the expanded condition to the compressed condition by compressing the paddle in the direction Y and extending a length of the paddle in the direction X. In the illustrated embodiment, the length of the side members <b>1807</b> of the paddle <b>606</b> are extended when the paddle is in the compressed condition. Referring to <figref idref="DRAWINGS">FIG. 18C</figref>, in certain embodiments, when the paddles <b>606</b> are disposed in the delivery device <b>601</b> and in the compressed condition, the side members <b>1807</b> of the paddles cross each other.
0123Referring to <figref idref="DRAWINGS">FIGS. 19A-19D</figref>, another exemplary embodiment of a valve repair device <b>602</b> includes paddles <b>606</b> having a mesh structure <b>1901</b>. In certain embodiments, the mesh structure <b>1901</b> of the paddles <b>606</b> is compressible, which allows the paddles <b>606</b> to be disposed in a delivery device <b>601</b> (e.g., a catheter) that has a small diameter (as shown in <figref idref="DRAWINGS">FIG. 19C</figref>) for delivery of the valve repair device <b>602</b> to a native valve of a patient, and also allows the paddles <b>606</b> to expand (as shown in <figref idref="DRAWINGS">FIGS. 19A-19B</figref>) upon exiting the delivery device <b>601</b> such that the paddles <b>606</b> have a larger surface area for engaging the native valve of the patient. The valve repair device <b>602</b> can take any suitable form, such as, for example, any form described in the present application. The valve repair device <b>602</b> can be moved between the open and closed position, and be attached to a native valve, by a valve repair system, such as, for example, any valve repair system described in the present application.
0124<figref idref="DRAWINGS">FIGS. 19A-19B</figref> illustrate the valve repair device <b>602</b> in the open position. When the valve repair device <b>602</b> is in the expanded and open position, the paddles <b>606</b> extend outward to create wide opening <b>614</b> between the paddles <b>606</b> and gripping members <b>608</b> of the valve repair device <b>602</b>. In certain embodiments, the paddles <b>606</b> include a material disposed over the mesh structure <b>1901</b>, such as, for example, a woven material, an electrospun material, or any other material that is capable of promoting tissue ingrowth and protecting liners of the delivery device <b>601</b> (<figref idref="DRAWINGS">FIG. 6</figref>) during tracking. In certain embodiments, the material <b>1605</b> can be a blood-impermeable cloth, such as a PET cloth or biocompatible covering material such as a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.
0125In various embodiments, the paddles <b>606</b> are configured to flex to place less stress on valve tissue when the valve repair device <b>602</b> is attached to the valve tissue. When the paddles <b>606</b> are in the expanded condition, the paddles have a width W. The width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, the width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W can be less than 5 mm.
0126Referring to <figref idref="DRAWINGS">FIG. 19C</figref>, the paddles <b>606</b> are in a compressed condition when the paddles are disposed in a delivery device <b>601</b>. When the paddles <b>606</b> are in the compressed condition, the paddles have a width H. The width H can be, for example between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles <b>606</b> is equal to a width D of the delivery opening <b>716</b> of the delivery device <b>601</b>. The ratio between the width W of the paddles in the expanded condition and the width H of the paddles in the compressed condition can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In alternative embodiments, the ratio between the width W and the width H can be more than 4 to 1. Referring to <figref idref="DRAWINGS">FIG. 19D</figref>, a paddle <b>606</b> is moved from the expanded condition to the compressed condition by compressing the paddle in the direction Y and extending a length of the paddle in the direction X.
0127Referring to <figref idref="DRAWINGS">FIGS. 20A-20B</figref>, another exemplary embodiment of a valve repair device includes paddles <b>606</b> that are compressible, which allows the paddles <b>606</b> to be disposed in a delivery device <b>601</b> (e.g., a catheter) that has a small diameter (as shown in <figref idref="DRAWINGS">FIG. 20A</figref>) for delivery of the valve repair device to a native valve of a patient, and also allows the paddles <b>606</b> to expand (as shown in <figref idref="DRAWINGS">FIG. 20B</figref>) upon exiting the delivery device <b>601</b> such that the paddles <b>606</b> have a larger surface area for engaging the native valve of the patient. The paddles <b>606</b> can be included on a valve repair device <b>602</b> that takes any suitable form, such as, for example, any form described in the present application. The valve repair device (and paddles <b>606</b>) can be attached to a native valve by a valve repair system, such as, for example, any valve repair system described in the present application.
0128<figref idref="DRAWINGS">FIG. 20A</figref> illustrates the paddle <b>606</b> in a compressed condition inside a delivery device <b>601</b>. The paddle includes an opening <b>2001</b> that allows a portion of the paddle to expand upon being deployed from the delivery device <b>601</b>. In the compressed condition, the paddle <b>606</b>, for example, can have a width H between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles <b>606</b> is equal to a width D of the delivery opening <b>716</b> of the delivery device <b>601</b>. <figref idref="DRAWINGS">FIG. 20B</figref> illustrates the paddle <b>606</b> in an expanded condition. In the expanded condition, the paddle <b>606</b>, for example, can have a width W between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, the width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W can be less than 5 mm. The ratio between the width W of the paddles in the expanded condition and the width H of the paddles in the compressed condition can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In alternative embodiments, the ratio between the width W and the width H can be more than 4 to 1. Referring to <figref idref="DRAWINGS">FIG. 20B</figref>, a paddle <b>606</b> is moved from the expanded condition to the compressed condition by compressing the paddle in the direction Y. In various embodiments, the paddles <b>606</b> are configured to flex to place less stress on valve tissue when the valve repair device <b>602</b> is attached to the valve tissue. In certain embodiments, the paddles <b>606</b> include a material disposed over the paddle <b>606</b>, such as, for example, any material that is capable of promoting tissue ingrowth and protecting liners of the delivery device <b>601</b> (<figref idref="DRAWINGS">FIG. 6</figref>) during tracking. In certain embodiments, the material can be a blood-impermeable cloth, such as a PET cloth or biocompatible covering material such as a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.
0129<figref idref="DRAWINGS">FIGS. 21A-21B</figref> illustrate another exemplary embodiment of a valve repair system <b>600</b>, in which the valve repair system <b>600</b> includes a valve repair device <b>602</b> having extendable paddles. The valve repair system <b>600</b> can take any suitable form, such as, for example, any form described in the present application. In the illustrated embodiment, the valve repair device <b>602</b> includes paddles <b>606</b> that are telescoping such that a length L of the paddles can be altered. That is, the paddles <b>606</b> include a main portion <b>2110</b> and an extendable portion <b>2112</b>. The extendable portion <b>2112</b> is able to be housed within the main portion <b>2110</b> to create paddles having a shorter length L (as shown in <figref idref="DRAWINGS">FIG. 21A</figref>), and the extendable portion <b>2112</b> is able to be extended outside of the main portion to create paddles having a longer length L (as shown in <figref idref="DRAWINGS">FIG. 21B</figref>). The ratio between the shorter length L (as shown in <figref idref="DRAWINGS">FIG. 21A</figref>) and the longer length L (as shown in <figref idref="DRAWINGS">FIG. 21B</figref>) can be, for example, 1.25 to 1 or more, such as 1.5 to 1 or more, such as 2 to 1 or more, such as 2 to 1 or more, such as 4 to 1 or more, such as 5 to 1 or more.
0130In one embodiment, the main portion <b>2110</b> is a hollow conduit having an opening, and the extendable portion <b>2112</b> is a rod or conduit configured to be housed in the opening of the hollow member. In certain embodiments, the extendable portion <b>2112</b> is spring loaded, such that the extendable portion <b>2112</b> is biased toward the extended position, and a latch member is disposed in a locked position to maintain the extendable portion <b>2112</b> housed within the main portion <b>2110</b> in the non-extended position. Movement of the latch member from the locked position to an unlocked position causes the spring-loaded extendable portion <b>2112</b> to move outside the main portion <b>2110</b> and into the extended position. In addition, the extendable portion <b>2112</b> can be moved back within the main portion <b>2110</b> and the latch member can be moved from the unlocked position to the locked position to move the paddles from the extended position to the retracted position. The latch member can be moved between the locked an unlocked position by any suitable means, such as, for example, a rod that engages the latch member to move the latch member between the locked and unlocked positions. In an alternative embodiment, a suture or wire extends through the main portion <b>2110</b> and engages the extendable portion <b>2112</b> to maintain the extendable portion <b>2112</b> in the non-extended position, and removal of the suture or wire allows the spring-loaded extendable portion to move outside the main portion <b>2110</b> and into the extended position.
0131Referring to <figref idref="DRAWINGS">FIG. 21A</figref>, the valve repair device <b>602</b> is shown with the paddles <b>606</b> in a non-extended position, and the valve repair device is positioned to engage valve tissue <b>820</b>. Referring to <figref idref="DRAWINGS">FIG. 21B</figref>, after the valve repair device <b>602</b> is placed in position to engage the valve tissue <b>820</b>, the extendable portions <b>2112</b> of the paddles <b>606</b> are extended such that the paddles have a larger surface area for engaging the valve tissue. After the paddles <b>606</b> are extended to a desired length L, the valve repair device <b>602</b> is closed to secure the valve repair device to the valve tissue <b>820</b>, and the valve repair device is removed from the valve repair system <b>600</b>. In certain embodiments, the valve repair device <b>602</b> is configured such that the extendable portions <b>2112</b> of the paddles can be extended or retracted after the valve repair device is secured to the valve tissue <b>820</b>, such that the tension on the valve tissue can be increased or decreased depending on the patient and the procedural circumstances. For example, in embodiments in which the valve tissue <b>820</b> is a patient's mitral valve, a valve with excess leaflet material or chordal damage may need more tension to sufficiently seal the mitral valve, or a valve with short non-coapting leaflets may need less tension for a sufficiently seal the mitral valve. The valve repair device can be moved from the open position to a closed position and removed from the valve repair system <b>600</b> in any suitable manner, such as, for example, any manner described in the present application.
0132Referring to <figref idref="DRAWINGS">FIGS. 22-26</figref>, in certain embodiments, the gripper control mechanism <b>611</b> is configured to control each of the gripping members <b>608</b> independent of each other. Independent control for each of the gripping members <b>608</b> is advantageous because the openings <b>614</b> between the paddles <b>606</b> and the gripping members can be adjusted independently as the valve repair device <b>602</b> is being attached to valve tissue (e.g., a mitral valve of a patient). In addition, independent gripper control will also be advantageous in situations in which one gripping member <b>608</b> and one paddle <b>606</b> sufficiently secure the valve repair device <b>602</b> to a first portion of valve tissue, but the other gripping member and the other paddle fail to connect the valve repair device to a second portion of valve tissue. In this situation, the gripper control mechanism <b>611</b> can be used to control only the gripping member <b>608</b> that is not connected to the valve tissue to create an opening <b>614</b> for receiving the second portion of the valve tissue, and, after the second portion of the valve tissue is disposed in the opening, the unattached gripping member and the unattached paddle can be closed to secure the valve repair device <b>602</b> to the second portion of the valve tissue.
0133Still referring to <figref idref="DRAWINGS">FIGS. 22-26</figref>, an exemplary embodiment of a valve repair system <b>600</b> includes a delivery device <b>601</b> and a valve repair device <b>602</b>, in which delivery device is configured to deliver the valve repair device to the native valve of a patient, and in which the valve repair device is configured to attach to leaflets of a native valve to repair the native valve of the patient. The delivery device <b>601</b> can take any suitable form that is capable of delivering the valve repair device <b>602</b> to the native valve of a patient, such as, for example, any form described in the present application. The valve repair device <b>602</b> is similar to the previously described valve repair device and includes a base assembly <b>604</b>, a pair of paddles <b>606</b>, and a pair of gripping members <b>608</b>. The base assembly <b>604</b> of the valve repair device <b>602</b> has a shaft <b>603</b>, a coupler <b>605</b> configured to move along the shaft, and a lock <b>607</b> configured to lock the coupler in a stationary position on the shaft. The valve repair device <b>602</b> can take any suitable form, such as, for example, any form described in the present application. The valve repair system <b>600</b> can also include a paddle control mechanism <b>610</b>, a gripper control mechanism <b>611</b>, and a lock control mechanism <b>612</b>. The paddle control mechanism <b>610</b> is mechanically attached to the coupler <b>605</b> to move the coupler along the shaft <b>603</b>, which causes the paddles <b>606</b> to move between the open and closed positions. The paddle control mechanism <b>610</b> can take any suitable form, such as, for example, any form described in the present application. The lock control mechanism <b>612</b> is configured to move the coupler <b>605</b> between the locked and unlocked conditions. The lock control mechanism <b>612</b> can take any suitable form, such as, for example, any form described in the present application.
0134Referring to <figref idref="DRAWINGS">FIG. 22</figref>, an exemplary embodiment of a gripper control mechanism <b>611</b> includes a first gripper control member <b>2202</b> and a second gripper control member <b>2204</b>. The first gripper control member <b>2202</b> is configured to move the gripping member <b>608</b><i>a </i>in the direction X, and the second gripper control member <b>2204</b> is configured to move the gripping member <b>608</b><i>b </i>in the direction Z. Movement of the gripping member <b>608</b><i>a </i>in the direction X will adjust the width W of the opening <b>614</b><i>a </i>between the gripping member <b>608</b><i>a </i>and the paddle <b>606</b><i>a</i>, and movement of the gripping member <b>608</b><i>b </i>in the direction Z will adjust the width H of the opening between the gripping member <b>608</b><i>b </i>and the paddle <b>606</b><i>b</i>. The gripper control members <b>2202</b>, <b>2204</b> can take any suitable form that is capable of independently moving the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>. In the illustrated embodiment, the gripper control members <b>2202</b>, <b>2204</b> are lines, such as sutures, wires, etc. that are removably attached to each of the gripper members <b>608</b><i>a</i>, <b>608</b><i>b</i>, respectively, with both ends of the line extending through the delivery opening <b>716</b> of the delivery device <b>601</b>. The gripper control members <b>2202</b>, <b>2204</b> can be independently pulled into and cast from the catheter to independently control the positions of the gripping members <b>608</b><i>a</i>, <b>608</b><i>b. </i>
0135Referring to <figref idref="DRAWINGS">FIGS. 22A-22D</figref>, another exemplary embodiment of valve repair system <b>600</b> is shown with another embodiment of a gripper control mechanism <b>611</b> used to control the gripping members <b>608</b><i>a</i>-<i>d </i>of another exemplary embodiment of a valve repair device <b>602</b>. For illustrative purposes, the paddles <b>606</b> of the valve repair device <b>602</b> are not shown on in <figref idref="DRAWINGS">FIGS. 22A-22D</figref>, but it should be noted that the valve repair device <b>602</b> also includes paddles <b>606</b> that interact with the gripping members <b>608</b><i>a</i>-<i>d </i>to secure the valve repair device <b>602</b> to valve tissue, and the paddles <b>606</b> can take any suitable form, such as, for example, any form described in the present application. <figref idref="DRAWINGS">FIG. 22A</figref> illustrates the valve repair system <b>600</b> with the each of the four gripping members <b>608</b><i>a</i>-<i>d </i>in a first position, and <figref idref="DRAWINGS">FIG. 22C</figref> illustrates the valve repair system <b>600</b> with the one of the gripping members <b>608</b><i>a </i>moved to a second position. <figref idref="DRAWINGS">FIG. 22B</figref> is a top view (as indicated by the lines <b>22</b>B-<b>22</b>B shown in <figref idref="DRAWINGS">FIG. 22A</figref>) of the valve repair system <b>600</b> with each of the gripping members <b>608</b><i>a</i>-<i>d </i>being disposed in a first position. <figref idref="DRAWINGS">FIG. 22D</figref> is a cross-sectional view (as indicated by the lines C-C shown in <figref idref="DRAWINGS">FIG. 22C</figref>) of the valve repair system <b>600</b> with the gripping member <b>608</b><i>a </i>disposed the second position. Each of the four gripping members can be independently moved in the same manner as is illustrated by the gripping member <b>608</b><i>a. </i>
0136The valve repair device <b>602</b> includes a first gripping member <b>608</b><i>a</i>, a second gripping member <b>608</b><i>b</i>, a third gripping member <b>608</b><i>c</i>, and a fourth gripping member <b>608</b><i>d</i>. Each of the gripping members <b>608</b><i>a</i>-<i>d </i>include a barbed portion <b>609</b><i>a</i>-<i>d </i>for securing the gripping members <b>608</b><i>a</i>-<i>d </i>to valve tissue. The gripper control mechanism <b>611</b> includes a first gripper control member <b>2202</b><i>a </i>configured to control the first gripping member <b>608</b><i>a</i>, a second gripper control member <b>2202</b><i>b </i>configured to control the second gripping member <b>608</b><i>b</i>, a third gripper control member <b>2202</b><i>c </i>configured to control the third gripping member <b>608</b><i>c</i>, and a fourth gripper control member <b>2202</b><i>d </i>configured to control the fourth gripping member <b>608</b><i>d</i>. In particular, the first gripper control member <b>2202</b><i>a </i>is configured to move the gripping member <b>608</b><i>a </i>in the direction X, and the second gripper control member <b>2202</b><i>b </i>is configured to move the second gripping member <b>608</b><i>b </i>in the direction X. In addition, the third gripper control member <b>2202</b><i>c </i>is configured to move the gripping member <b>608</b><i>c </i>in the direction Z, and the fourth gripper control member <b>2202</b><i>d </i>is configured to move the fourth gripping member <b>608</b><i>d </i>in the direction Z. Movement of the gripping members <b>608</b><i>a</i>-<i>b </i>in the direction X will adjust the width of the opening between the gripping members <b>608</b><i>a</i>-<i>b </i>and the corresponding paddle <b>606</b>, and movement of the gripping members <b>608</b><i>c</i>-d in the direction Z will adjust the width of the opening between the gripping members <b>608</b><i>c</i>-<i>d </i>and the corresponding paddle. The gripper control mechanism <b>611</b> is configured to move each of the gripping members <b>608</b><i>a</i>-<i>d </i>independently of each other. The gripper control members <b>2202</b><i>a</i>-<i>d </i>can take any suitable form that is capable of independently moving the gripping members <b>608</b><i>a</i>-<i>d</i>. In the illustrated embodiment, the gripper control members <b>2202</b><i>a</i>-<i>d </i>are lines, such as sutures, wires, etc. that are removably attached to each of the gripper members <b>608</b><i>a</i>-<i>d</i>, respectively, with both ends of the line extending through the delivery opening <b>716</b> of the delivery device <b>601</b>. The gripper control members <b>2202</b><i>a</i>-<i>d </i>can be independently pulled into and released from the catheter to independently control the positions of the gripping members <b>608</b><i>a</i>-<i>d. </i>
0137Referring to <figref idref="DRAWINGS">FIGS. 22A and 22B</figref>, each of the gripping members <b>608</b><i>a</i>-<i>d </i>are shown in an extended position. Referring to <figref idref="DRAWINGS">FIGS. 22C and 22D</figref>, the first gripping member <b>608</b><i>a </i>is shown after the first gripper control member <b>2202</b><i>a </i>of the gripper control mechanism was pulled into the catheter causes the first gripping member <b>608</b><i>a </i>to move inward toward the shaft <b>603</b> in the direction X, and the other gripping members <b>608</b><i>b</i>-<i>d </i>remained in the position shown in <figref idref="DRAWINGS">FIGS. 22A and 22B</figref>. In other words, the illustrated embodiment shown in <figref idref="DRAWINGS">FIGS. 22A-22D</figref> show a first gripping member <b>608</b><i>a </i>being independently controlled relative to the other gripping members <b>608</b><i>b</i>-<i>d</i>. While the illustrated embodiment shows the first gripping member <b>608</b><i>a </i>being independently controlled, it should be understood that each of the gripping members <b>608</b><i>a</i>-<i>d </i>can be independently controlled by the corresponding gripper control member <b>2202</b><i>a</i>-<i>d </i>of the gripper control mechanism <b>611</b>. In addition, while the illustrated embodiment of <figref idref="DRAWINGS">FIGS. 22A-22D</figref> illustrate a valve repair assembly <b>600</b> having four gripping members <b>608</b><i>a</i>-<i>d </i>and four gripper control members <b>2202</b><i>a</i>-<i>d</i>, it should be understood that any suitable number of gripping members and gripper control members can be utilized, and any number of the gripping members can be independently controlled by the gripper control mechanism. In addition, each of the gripping members <b>608</b><i>a</i>-<b>608</b><i>d </i>can have any of the configurations disclosed in this application and each of the control mechanisms <b>2202</b><i>a</i>-<b>2202</b><i>d </i>can have any of the forms disclosed in this application.
0138Referring to <figref idref="DRAWINGS">FIG. 23</figref>, another exemplary embodiment of a gripper control mechanism <b>611</b> includes a single line <b>2302</b>, such as a suture or wire, that is removably attached to the gripping members <b>608</b><i>a</i>, <b>608</b><i>b </i>and removably fixed between a placement shaft <b>613</b> and a <b>603</b> shaft of the valve repair device. The connection <b>615</b> between the placement shaft <b>613</b> and a <b>603</b> shaft of the valve repair device can be at a wide variety of different positions. In the illustrate example, the connection <b>615</b> is aligned or substantially aligned with ends of the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>. However, in other embodiments, the connection <b>615</b> can more distal, such as at a most proximal position that the coupler <b>605</b> can reach (see for example, the bailout positions of the coupler illustrated by <figref idref="DRAWINGS">FIGS. 45C and 46D</figref>). The single line <b>2302</b> is connected between the shaft <b>613</b> and the shaft <b>603</b>, such that the single line <b>2302</b> can independently control the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>. That is, movement of a first portion <b>2303</b> of the line <b>2302</b> in the direction Y will adjust the width W between the gripping member <b>608</b><i>a </i>and the paddle <b>606</b><i>a</i>, but will not adjust the width H between the gripping member <b>608</b><i>b </i>and the paddle <b>606</b><i>b</i>. Similarly, movement of a second portion <b>2305</b> of the line <b>2302</b> in the direction M will adjust the width H between the gripping member <b>608</b><i>b </i>and the paddle <b>606</b><i>b</i>, but will not adjust the width W between the gripping member <b>608</b><i>a </i>and the paddle <b>606</b><i>a</i>. After the valve repair device <b>602</b> is in the closed position and secured to valve tissue, the placement shaft <b>613</b> is detached from the shaft <b>603</b> of the valve repair device <b>602</b>. The detachment of the shaft <b>603</b> from the and the shaft <b>613</b> causes the line to be released. The line <b>2302</b> can then be retracted into the catheter to release the gripping members <b>608</b><i>a</i>, <b>608</b><i>b </i>by pulling one end of the line <b>2302</b> into the catheter. Pulling one end of the line into the catheter pulls the other end of the line through the gripping members <b>608</b><i>a</i>, <b>608</b><i>b </i>and then into the catheter. Any of the lines described herein can be retracted in this manner.
0139Referring to <figref idref="DRAWINGS">FIG. 24</figref>, in certain embodiments, the placement shaft <b>613</b> and the shaft <b>603</b> of the device <b>602</b> can be a hollow an fit over a coupling shaft <b>2400</b> that holds the shafts <b>613</b>, <b>603</b> together. The shaft <b>603</b> of the device <b>602</b> can include a protruding portion <b>2406</b> and a recessed receiving portion <b>2408</b>. The positioning shaft <b>613</b> can include a protruding portion <b>2407</b> and a recessed receiving portion <b>2409</b>. When the shafts <b>613</b>, <b>603</b> are coupled, the protruding portion <b>2406</b> of the shaft <b>603</b> is disposed in the receiving portion <b>2409</b> of the shaft <b>613</b>, and the protruding portion <b>2407</b> of the shaft <b>613</b> is disposed in the receiving portion <b>2408</b> of the shaft <b>603</b>. The shafts <b>613</b>, <b>603</b> can be connected in a wide variety of different ways. For example, the shaft <b>613</b> can include a bore or channel <b>2411</b> that is aligned with a bore or channel <b>2413</b> of the shaft <b>602</b> when the protruding portions <b>2406</b>, <b>2407</b> are disposed in the receiving portions <b>2408</b>, <b>2409</b>, respectively. When the openings <b>2411</b>, <b>2413</b> are aligned and the retaining shaft <b>2400</b> is placed into the openings <b>2411</b>, <b>2413</b> in the direction X, the shafts <b>613</b>, <b>603</b> are retained together. When the placement shaft is removed from the openings <b>2411</b>, <b>2413</b> in the direction Z, protruding portions <b>2406</b>, <b>2407</b> can be removed from the receiving portions <b>2408</b>, <b>2409</b>, such that the device <b>602</b> is detached from the placement shaft <b>613</b>.
0140Still referring to <figref idref="DRAWINGS">FIG. 24</figref>, when the shafts <b>613</b>, <b>603</b> are secured to each other, an aperture <b>2415</b> is created at interface <b>2417</b> between the shafts <b>613</b>, <b>603</b>. The aperture <b>2415</b> is configured to secure the line <b>2302</b> between the shafts <b>613</b>, <b>603</b> to allow for independent control of the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>. That is, the aperture <b>2415</b> is configured such that the line <b>2302</b> does not move relative to the aperture <b>2416</b> when the shafts <b>613</b>, <b>603</b> are attached. Upon detachment of the shafts <b>613</b>, <b>603</b>, the line <b>2302</b> is released from the aperture <b>2415</b> and can be removed from the valve repair device <b>602</b>. The line <b>2302</b> can then be retracted into the catheter to release the gripping members as described above.
0141Referring to <figref idref="DRAWINGS">FIGS. 23 and 24A-24B</figref>, in an alternative embodiment, the line <b>2302</b> of the gripper control mechanism <b>610</b> is secured between the placement shaft <b>613</b> and the shaft <b>603</b> of by a threaded connection to independently control the gripper members <b>608</b><i>a</i>, <b>608</b><i>b</i>. Referring to <figref idref="DRAWINGS">FIG. 24A</figref>, the placement shaft <b>613</b> includes a male threaded member <b>2419</b>, and the shaft <b>603</b> includes a female threaded member <b>2421</b> configured to receive the male threaded member <b>2419</b> of the placement shaft <b>613</b>. However, the male and female threads can be reversed. The placement shaft <b>613</b> is secured to the shaft <b>603</b> by inserting the male threaded member <b>2419</b> into the female threaded member <b>2421</b> of the shaft <b>603</b>. The line <b>2302</b> of the gripper control mechanism <b>611</b> is disposed between the placement shaft <b>613</b> and the shaft <b>603</b> such that, when the placement shaft <b>613</b> is secured to the shaft <b>603</b>, the line <b>2302</b> is compressed (as shown by reference character M) between the placement shaft <b>613</b> and the shaft <b>603</b>. The compression M of the line <b>2302</b> between the placement shaft <b>613</b> and the shaft <b>603</b> causes the line <b>2302</b> to not move relative to the engagement point <b>2423</b> between the placement shaft <b>613</b>, the shaft <b>603</b>, and the line <b>2302</b> when the line <b>2302</b> is controlling the gripping members <b>608</b><i>a</i>, <b>608</b><i>b</i>. As a result, the compression M and resulting retention of the line <b>2302</b> allows the line <b>2302</b> to independently control the gripping members <b>608</b><i>a</i>, <b>608</b><i>b. </i>
0142Referring to <figref idref="DRAWINGS">FIG. 25</figref>, another exemplary embodiment of a gripper control mechanism <b>611</b> includes a first gripper control member <b>2502</b> and a second gripper control member <b>2504</b>. The first gripper control member <b>2502</b> is configured to move the gripping member <b>608</b><i>a </i>bi-directionally in the direction X, and the second gripper control member <b>2504</b> is configured to move the gripping member <b>608</b><i>b </i>bi-directionally in the direction Z. Movement of the gripping member <b>608</b><i>a </i>in the direction X will adjust the width W of the opening <b>614</b><i>a </i>between the gripping member <b>608</b><i>a </i>and the paddle <b>606</b><i>a</i>, and movement of the gripping member <b>608</b><i>b </i>in the direction Z will adjust the width H of the opening between the gripping member <b>608</b><i>b </i>and the paddle <b>606</b><i>b</i>. In the illustrated embodiment, the gripper control members <b>2202</b>, <b>2204</b> include a push/pull link <b>2503</b>, <b>2505</b>, such as, for example, a catheter, a flexible rod, or a stiff wire and a coupler <b>2506</b>, <b>2507</b>. Each push/pull link <b>2503</b>, <b>2505</b> extends from the delivery device <b>601</b> and is removably attached to the corresponding gripping member <b>608</b><i>a</i>, <b>608</b><i>b </i>by a coupler <b>2506</b>, <b>2507</b>. The link <b>2503</b> is configured to be pushed and pulled in the direction Y. Movement of the link <b>2503</b> in the direction Y causes the gripping member <b>608</b><i>a </i>to move in the direction X. Similarly, the link <b>2505</b> is configured to be pushed and pulled in the direction M, and movement of the catheter <b>2505</b> in the direction M causes the catheter <b>2505</b> to move the gripping member <b>608</b><i>b </i>in the direction H.
0143In another embodiment of a the gripper control mechanism <b>611</b> is shown in <figref idref="DRAWINGS">FIG. 25A</figref>. in this embodiment, the gripper control members <b>2202</b>, <b>2204</b> include a suture <b>2511</b>, <b>2513</b> and a flexible wire <b>2503</b>, <b>2505</b>. In this embodiment, the first flexible wire <b>2503</b> includes a loop <b>2517</b> for receiving the first suture <b>2511</b> and for engaging a gripping member <b>608</b><i>a </i>(<figref idref="DRAWINGS">FIG. 25</figref>), and the second flexible wire <b>2505</b> includes a loop <b>2519</b> for receiving the second suture <b>2513</b> and for engaging the gripping member <b>608</b><i>b </i>(<figref idref="DRAWINGS">FIG. 25</figref>). The sutures <b>2517</b>, <b>2519</b> are removably attached to each of the gripper members <b>608</b><i>a</i>, <b>608</b><i>b</i>, respectively, with both ends of the line extending through the delivery device <b>601</b> as described above. Each of the wires <b>2503</b>, <b>2505</b> extends from the delivery device <b>601</b> and the loops <b>2517</b>, <b>2519</b> of the respective wires <b>2503</b>, <b>2505</b> are able to move along the corresponding sutures <b>2511</b>, <b>2513</b>, such that the loops <b>2517</b>, <b>2519</b> can engage the corresponding gripping member <b>608</b><i>a</i>, <b>608</b><i>b </i>to move the gripping members (e.g., move the gripping members as described with respect to <figref idref="DRAWINGS">FIG. 25</figref>). The wires <b>2503</b>, <b>2505</b> can be made of, for example, steel, NiTi, or other wire or a plastic material. In certain embodiments, the wires <b>2503</b>, <b>2505</b> can have a diameter of between about 0.1 mm and 0.35 mm, such as between about 0.15 mm and 0.3 mm, such as between about 0.2 mm and 0.25 mm.
0144Referring to <figref idref="DRAWINGS">FIG. 26</figref>, another exemplary embodiment of a gripper control mechanism <b>611</b> includes a first catheter <b>2603</b>, a second catheter <b>2605</b>, and single line <b>2604</b>, such as a wire or suture. The first catheter <b>2603</b> and line <b>2604</b> are configured to move the gripping member <b>608</b><i>a </i>in the direction X, and the second catheter <b>2605</b> and line <b>2604</b> configured to move the gripping member <b>608</b><i>b </i>in the direction Z. Movement of the gripping member <b>608</b><i>a </i>in the direction X will adjust the width W of the opening <b>614</b><i>a </i>between the gripping member <b>608</b><i>a </i>and the paddle <b>606</b><i>a</i>, and movement of the gripping member <b>608</b><i>b </i>in the direction Z will adjust the width H of the opening between the gripping member <b>608</b><i>b </i>and the paddle <b>606</b><i>b</i>. The line <b>2604</b> extends from the delivery device <b>601</b> through the catheters <b>2603</b>, <b>2605</b> and is threaded through openings in both gripping member <b>608</b><i>a</i>, <b>608</b><i>b</i>. Each catheter <b>2603</b>, <b>2605</b> is configured to engage and move the corresponding gripping member <b>608</b><i>a</i>, <b>608</b><i>b</i>. In particular, the catheter <b>2603</b> is configured to be pushed in the direction Y while the line <b>2604</b> is payed out of the catheter <b>2603</b> or tension in the line is reduced. The catheter <b>2603</b> is configured to be pulled in the direction Y while the line <b>2604</b> is pulled into the catheter <b>2603</b> or tension in the line is increased. Movement of the catheter <b>2603</b> in the direction Y causes the catheter <b>2603</b> to move the gripping member <b>608</b><i>a </i>in the direction X. Similarly, the catheter <b>2605</b> is configured to be pushed in the direction M while the line <b>2604</b> is payed out of the catheter <b>2605</b> or tension in the line is reduced. The catheter <b>2605</b> is configured to be pulled in the direction M while the line <b>2604</b> is pulled into the catheter <b>2605</b> or tension in the line is increased. Movement of the catheter <b>2505</b> in the direction M causes the catheter <b>2505</b> to move the gripping member <b>608</b><i>b </i>in the direction H. In an alternative embodiment, the gripper control mechanism <b>611</b> described above with reference to <figref idref="DRAWINGS">FIG. 26</figref> can include a first flexible wire with a loop (e.g., the flexible wire <b>2503</b> with the loop <b>2517</b> shown in <figref idref="DRAWINGS">FIG. 25A</figref>) and a second flexible wire with a loop (e.g., the flexible wire <b>2505</b> with the hoop <b>2519</b> shown in <figref idref="DRAWINGS">FIG. 25A</figref>), and the single line <b>2604</b> extends through the hoop <b>2517</b>, <b>2519</b> of each of the wires <b>2503</b>.
0145Referring to <figref idref="DRAWINGS">FIGS. 27A-29B</figref>, in certain embodiments, the valve repair device <b>602</b> and the paddle control mechanism <b>610</b> for a valve repair device <b>602</b> are configured such that each of the paddles <b>606</b> can be controlled independent of each other. Independent control for each of the paddles <b>606</b> is advantageous because the openings <b>614</b> between the paddles and the gripping members <b>608</b> can be adjusted independently as the valve repair device <b>602</b> is being attached to valve tissue (e.g., a mitral valve of a patient). In addition, independent paddle control will also be advantageous in situations in which one gripping member <b>608</b> and one paddle <b>606</b> sufficiently secure the valve repair device <b>602</b> to a first portion of valve tissue, but the other gripping member and the other paddle fail to connect the valve repair device to a second portion of valve tissue. In this situation, the paddle control mechanism <b>610</b> can be used to control only the paddle <b>606</b> that is not connected to the valve tissue to create an opening <b>614</b> for receiving the second portion of the valve tissue, and, after the second portion of the valve tissue is disposed in the opening, the unattached gripping member and the unattached paddle can be closed to secure the valve repair device <b>602</b> to the second portion of the valve tissue.
0146Referring to <figref idref="DRAWINGS">FIGS. 27A-27C</figref>, the base assembly <b>604</b> of the valve repair device <b>602</b> includes a first shaft <b>603</b><i>a</i>, a second shaft <b>603</b><i>b</i>, a first coupler <b>605</b><i>a</i>, and a second coupler <b>605</b><i>b</i>. In addition, the paddle control mechanism <b>610</b> includes a first paddle control mechanism <b>2702</b> and a second paddle control mechanism <b>2704</b>. The first paddle control mechanism <b>2702</b> is configured to move the first coupler <b>605</b><i>a </i>along the shaft <b>603</b><i>a</i>, and the second paddle control mechanism <b>2704</b> is configured to move the second coupler <b>605</b><i>b </i>along the shaft <b>603</b><i>b</i>. Movement of the first coupler <b>605</b><i>a </i>along the shaft <b>603</b><i>a </i>causes the paddle <b>606</b><i>a </i>to move between an open position and a closed position, and movement of the second coupler <b>605</b><i>b </i>along the shaft <b>603</b><i>b </i>causes the paddle <b>606</b><i>b </i>to move between an open position and a closed position. In an alternative embodiment, the base assembly <b>604</b> can include a single shaft, a first coupler <b>605</b><i>a </i>attached to the single shaft, and a second coupler <b>605</b><i>b </i>attached to the single shaft. In this alternative embodiment, the paddle control mechanism <b>610</b> can include a first paddle control mechanism <b>2702</b> configured to move the first coupler <b>605</b><i>a </i>along the single shaft to cause the paddle <b>606</b><i>a </i>to move between an open position and a closed position, and a second paddle control mechanism <b>2704</b> configured to move the second coupler <b>605</b><i>b </i>along the single shaft to cause the paddle <b>606</b><i>b </i>to move between an open position and a closed position.
0147<figref idref="DRAWINGS">FIGS. 27A-27C</figref> illustrate the paddles of the valve repair device moving between an open position and a closed position. The base assembly <b>604</b> of the valve repair device <b>602</b> includes a first link <b>2721</b> extending from point A to point B, a second link <b>2722</b> extending from point B to point C, a third link <b>2723</b> extending from point C to point D, a fourth link <b>2724</b> extending from point D to point E, and a fifth link <b>2725</b> extending from point E to point F. The coupler <b>605</b><i>a </i>is movably attached to the shaft <b>603</b><i>a</i>, the coupler <b>605</b><i>b </i>is movably attached to the shaft <b>603</b><i>b</i>, and the shafts <b>603</b><i>a</i>, <b>603</b><i>b </i>are fixed to the third link <b>2723</b>. The first link <b>2721</b> is pivotaly attached to the coupler <b>605</b><i>a </i>at point A, such that movement of the coupler <b>605</b><i>a </i>along the shaft <b>603</b><i>a </i>moves the location of point A and, consequently, moves the first link <b>2721</b>. Similarly, the fifth link <b>2725</b> is pivotally attached to the coupler <b>605</b><i>b </i>at point F, such that movement of the coupler <b>605</b><i>b </i>along the shaft <b>603</b><i>b </i>moves the location of point F and, consequently moves the fifth link <b>2725</b>. The first link <b>2721</b> and the second link <b>2722</b> are pivotally attached to each other at point B, and the fifth link <b>2725</b> and the fourth link <b>2724</b> are pivotally attached to each other at point E. One paddle <b>606</b><i>a </i>is attached to the first link <b>2721</b> such that movement of the first link <b>2721</b> causes the paddle <b>606</b><i>a </i>to move, and the other paddle <b>606</b><i>b </i>is attached to the fifth link <b>2725</b> such that movement of the fifth link <b>2725</b> causes the paddle <b>606</b><i>b </i>to move.
0148Referring to <figref idref="DRAWINGS">FIG. 27A</figref>, the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>are in the open position. Referring to <figref idref="DRAWINGS">FIGS. 27A and 27B</figref>, the paddle <b>606</b><i>b </i>is moved from the open position (as shown in <figref idref="DRAWINGS">FIG. 27A</figref>) to the closed position (as shown in <figref idref="DRAWINGS">FIG. 27B</figref>) when the second paddle control mechanism <b>2704</b> moves the second coupler <b>605</b><i>b </i>along the shaft <b>603</b><i>b </i>in the direction Y, which causes a portion of the fifth link <b>2725</b> near point F to move in the direction H, and a portion of the fifth link <b>2725</b> near point E to move in the direction J. The paddle <b>606</b><i>b </i>is attached to the fifth link <b>2725</b> such that movement of the second coupler <b>605</b><i>b </i>in the direction Y causes the paddle <b>606</b><i>b </i>to move in the direction Z. In addition, the fourth link <b>2724</b> is pivotally attached to the fifth link <b>2725</b> at point E such that movement of the second coupler <b>605</b><i>b </i>in the direction Y causes the fourth link <b>2724</b> to move in the direction K. Referring to <figref idref="DRAWINGS">FIG. 27B</figref>, the paddle <b>606</b><i>b </i>moves in the direction Q when moving from the open position to the closed position. In an alternative embodiment in which the pivotal connection at point E between the fourth link <b>2724</b> and the fifth link <b>2725</b> is significantly lower than pivotal connection at point F between the fifth link <b>2725</b> and the second coupler <b>605</b><i>b</i>, movement of the paddle <b>606</b><i>b </i>from the open position to the closed position will act as shown in the embodiment shown in <figref idref="DRAWINGS">FIG. 27A</figref> except that the fourth link <b>2724</b> will initially move in the direction substantially opposite to the direction K as the paddle <b>606</b><i>b </i>is being closed. In any of the above-mentioned embodiments, the second paddle control mechanism <b>2704</b> can take any suitable form for moving the second coupler <b>605</b><i>b </i>along the shaft <b>603</b><i>b</i>, such as, for example, any form of a paddle control mechanism described in the present application.
0149Referring to <figref idref="DRAWINGS">FIGS. 27A and 27C</figref>, the paddle <b>606</b><i>a </i>is moved from the open position (as shown in <figref idref="DRAWINGS">FIG. 27A</figref>) to the closed position (as shown in <figref idref="DRAWINGS">FIG. 27C</figref>) when the first paddle control mechanism <b>2702</b> moves the first coupler <b>605</b><i>a </i>along the shaft <b>603</b><i>a </i>in the direction N, which causes a portion of the first link <b>2721</b> near point A to move in the direction L, and a portion of the first link <b>2721</b> near point B to move in the direction I. The paddle <b>606</b><i>a </i>is attached to the first link <b>2721</b> such that movement of the first coupler <b>605</b><i>a </i>in the direction N causes the paddle <b>606</b><i>a </i>to move in the direction V. In addition, the second link <b>2722</b> is pivotally attached to the first link <b>2721</b> at point B such that movement of the first coupler <b>605</b><i>a </i>in the direction N causes the second link <b>2722</b> to move in the direction R. Referring to <figref idref="DRAWINGS">FIG. 27C</figref>, the paddle <b>606</b><i>a </i>moves in the direction T when moving from the open position to the closed position. In an alternative embodiment in which the pivotal connection at point B between the first link <b>2721</b> and the second link <b>2722</b> is significantly lower than pivotal connection at point A between the first link <b>2721</b> and the first coupler <b>605</b><i>a</i>, movement of the paddle <b>606</b><i>a </i>from the open position to the closed position will act as shown in the embodiment shown in <figref idref="DRAWINGS">FIG. 27A</figref> except that the second link <b>2722</b> will initially move in the direction substantially opposite to the direction R as the paddle <b>606</b><i>b </i>is being closed. In any of the above-mentioned embodiments, the first paddle control mechanism <b>2702</b> can take any suitable form for moving the first coupler <b>605</b><i>a </i>along the shaft <b>603</b><i>a</i>, such as, for example, any form of a paddle control mechanism described in the present application.
0150Referring to <figref idref="DRAWINGS">FIGS. 28A-28C</figref>, in certain embodiments, the paddle control mechanism <b>610</b> includes a rack and pinion mechanism <b>2802</b> that is configured to selectively couple and decouple the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>from the shaft <b>603</b>. The rack and pinion mechanism <b>2802</b> includes a first member <b>2804</b> attached to the shaft <b>603</b> and a toothed member <b>2806</b><i>a</i>, <b>2806</b><i>b </i>attached to each of the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>and pivotally connected to a base member <b>2801</b> at connections points A, B. The first member <b>2804</b> is configured such that the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>can be moved between the open and closed positions independent of each other. In the illustrated embodiment, the first member <b>2804</b> has ribbed portion <b>2805</b> and an open portion <b>2807</b>. When the toothed member(s) <b>2806</b><i>a</i>, <b>2806</b><i>b </i>is aligned with the ribbed portion <b>2805</b> of the first member <b>2804</b>, the toothed member(s) <b>2806</b><i>a</i>, <b>2806</b><i>b </i>are configured to engage the ribbed portion <b>2805</b> such that movement of the shaft in the direction Y relative to the base member <b>2801</b> causes the toothed member <b>2806</b><i>a </i>to pivot about connection point A in the direction M to move the paddle <b>606</b><i>a </i>between an open position and a closed position in the direction H, and causes the toothed member <b>2806</b><i>b </i>to pivot about connection point B in the direction N to move the paddle <b>606</b><i>b </i>between an open position and a closed position in the direction Z. When the open portion <b>2807</b> of the first member <b>2804</b> is aligned with either of the toothed members <b>2806</b><i>a </i>or <b>2806</b><i>b</i>, the tooth member that is aligned with the open portion <b>2807</b> is not engaged by the ribbed portion <b>2805</b> of the paddle <b>606</b><i>a </i>or <b>606</b><i>b</i>. As a result, movement of the shaft <b>603</b> in the direction Y does not affect the position of the paddle <b>606</b><i>a </i>or <b>606</b><i>b. </i>
0151<figref idref="DRAWINGS">FIGS. 28A-28B</figref> illustrate the corkscrew mechanism <b>2802</b> in a first position. In the first position, the toothed members <b>2806</b><i>a</i>, <b>2806</b><i>b </i>for both paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>are aligned with the ribbed portion <b>2805</b> of the first member <b>2804</b>. Referring to <figref idref="DRAWINGS">FIG. 28A</figref>, when the shaft <b>603</b> is moved in the direction Y, the toothed members <b>2806</b><i>a</i>, <b>2806</b><i>b </i>both engage the ribbed portion <b>2805</b> of the first member, which causes both paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>to be moved between the open and closed positions. <figref idref="DRAWINGS">FIGS. 28C-28D</figref> illustrate the corkscrew mechanism <b>2802</b> in a second position. In the second position, the toothed member <b>2806</b><i>a </i>is aligned with the open portion <b>2807</b> of the first member <b>2804</b>, and the toothed member <b>2806</b><i>b </i>is aligned with the ribbed portion <b>2806</b> of the first member <b>2804</b>. Referring to <figref idref="DRAWINGS">FIG. 28C</figref>, when the shaft <b>603</b> is moved in the direction Y, the toothed member <b>2806</b><i>b </i>engages the ribbed portion <b>2805</b> of the first member <b>2804</b>, which causes the paddle <b>606</b><i>b </i>to be moved between the open and closed positions, and the toothed member <b>2806</b><i>a </i>does not engage the first member, which causes the paddle <b>606</b><i>a </i>to remain in a current position. <figref idref="DRAWINGS">FIGS. 28E-28F</figref> illustrate the corkscrew mechanism <b>2802</b> in a third position. In the third position, the toothed member <b>2806</b><i>b </i>is aligned with the open portion <b>2807</b> of the first member <b>2804</b>, and the toothed member <b>2806</b><i>a </i>is aligned with the ribbed portion <b>2806</b> of the first member <b>2804</b>. Referring to <figref idref="DRAWINGS">FIG. 28E</figref>, when the shaft <b>603</b> is moved in the direction Y, the toothed member <b>2806</b><i>a </i>engages the ribbed portion <b>2805</b> of the first member <b>2804</b>, which causes the paddle <b>606</b><i>a </i>to be moved between the open and closed positions, and the toothed member <b>2806</b><i>b </i>does not engage the first member, which causes the paddle <b>606</b><i>b </i>to remain in a current position. In certain embodiments, the rack and pinion mechanism <b>2802</b> is moved between the positions shown in <figref idref="DRAWINGS">FIGS. 28A-28F</figref> by rotating the shaft <b>603</b>. In various embodiments, the rack and pinion mechanism <b>2802</b> includes a mechanism configured to maintain the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>in a desired position when the paddles are aligned with the open portion <b>2807</b> of the first member <b>2804</b>, but is also configured to allow the paddles to move when the paddles are aligned with the ribbed portion <b>2805</b> of the first member <b>2804</b>. The mechanism can take any suitable form, such as, for example, a clutch mechanism, a biasing member, a friction element, etc.
0152Referring to <figref idref="DRAWINGS">FIGS. 29A-29B</figref>, the paddle control mechanism <b>610</b> is configured to move a coupler <b>605</b> along a shaft <b>603</b> to move the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>between the open and closed positions (similar to the embodiment shown in <figref idref="DRAWINGS">FIGS. 6-12</figref>), and a locking mechanism <b>207</b> is configured to lock the coupler <b>605</b> on the shaft <b>603</b> to maintain the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>in a desired position. In certain embodiments, as shown in <figref idref="DRAWINGS">FIGS. 29A-29B</figref>, each of the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>include a pin <b>2902</b><i>a</i>, <b>2902</b><i>b </i>and a slot <b>2904</b><i>a</i>, <b>2904</b><i>b</i>. The pin <b>2902</b><i>a </i>is configured to move in slot <b>2904</b><i>a</i>, and the pin <b>2902</b><i>b </i>is configured to move in slot <b>2904</b><i>b</i>. The pins <b>2902</b><i>a</i>, <b>2902</b><i>b </i>are also configured to be locked in the slots <b>2904</b><i>a</i>, <b>2904</b><i>b</i>. When a pin <b>2902</b><i>a</i>, <b>2902</b><i>b </i>is unlocked in a slot <b>2904</b><i>a</i>, <b>2904</b><i>b</i>, the corresponding paddle <b>606</b><i>a</i>, <b>606</b><i>b </i>remains in a current position when the paddle control mechanism <b>610</b> moves the coupler <b>605</b> along the shaft <b>603</b>. When a pin <b>2902</b><i>a</i>, <b>2902</b><i>b </i>is locked in a slot <b>2904</b><i>a</i>, <b>2904</b><i>b</i>, the corresponding paddle <b>606</b><i>a</i>, <b>606</b><i>b </i>moves between an open and closed position when the paddle control mechanism <b>610</b> moves the coupler <b>605</b> along the shaft <b>603</b>.
0153<figref idref="DRAWINGS">FIG. 29A</figref> illustrates the valve repair device <b>602</b> with the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>in an open position. <figref idref="DRAWINGS">FIG. 29B</figref> illustrates the valve repair device <b>602</b> with the pin <b>2902</b><i>a </i>unlocked in slot <b>2904</b><i>a</i>, and pin <b>2902</b><i>b </i>locked in slot <b>2904</b><i>b</i>. Referring to <figref idref="DRAWINGS">FIG. 29B</figref>, the lock <b>607</b> is in an unlocked condition such that the coupler <b>605</b> can be moved along the shaft <b>603</b>. Movement of the coupler <b>605</b> along the shaft <b>603</b> in the direction Y causes the paddle <b>606</b><i>b </i>to pivot about the locked pin <b>2902</b><i>b </i>such that the paddle <b>606</b><i>b </i>moves in the direction Z to a closed position. In addition, movement of the coupler <b>605</b> in the direction Y does not cause the paddle <b>606</b><i>a </i>to move because the pin <b>2902</b><i>a </i>is in an unlocked condition in the slot <b>2904</b><i>a</i>. Instead, movement of the coupler <b>605</b> in the direction Y causes the pin <b>2902</b><i>a </i>to move in the slot <b>2904</b><i>a</i>. Alternatively, the pin <b>2902</b><i>a </i>could be locked in slot <b>2904</b><i>a </i>and the pin <b>2902</b><i>b </i>could be unlocked in slot <b>2904</b><i>b</i>, such that movement of the coupler <b>605</b> in the direction Y would cause the paddle <b>606</b><i>a </i>to move to a closed position, and the paddle <b>606</b><i>b </i>to remain in the open position (by the pin <b>2902</b><i>b </i>moving in the slot <b>2904</b><i>b</i>). In addition, the pin <b>2902</b><i>a </i>could be locked in slot <b>2904</b><i>a </i>and the pin <b>2902</b><i>b </i>could be locked in slot <b>2904</b><i>b</i>, such that movement of the coupler <b>605</b> in the direction Y would cause both paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>to move to the closed position. The pins <b>2902</b><i>a</i>, <b>2902</b><i>b </i>can be locked in the slot <b>2904</b><i>a</i>, <b>2904</b><i>b </i>by any suitable means, such as, for example, any means described herein with reference to lock <b>607</b>.
0154Referring to <figref idref="DRAWINGS">FIG. 30</figref>, in certain situations, the mitral valve <b>3001</b> of a patient can have a wide gap <b>3002</b> between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> when the mitral valve is in a closed position (i.e., during the systolic phase). For example, the gap <b>3002</b> can have a width W between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, such as about 10 mm. In some situations, the gap <b>3002</b> can have a width W greater than 15 mm. In any of the above-mentioned situations, a valve repair device is desired that is capable of engaging the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> to close the gap <b>3002</b> and prevent regurgitation of blood through the mitral valve <b>3001</b>.
0155<figref idref="DRAWINGS">FIGS. 31A-37D</figref> provide various embodiments of valve repair devices <b>602</b> that are configured to close a wide gap <b>3002</b> (<figref idref="DRAWINGS">FIG. 30</figref>) between the anterior leaflet <b>3003</b> and posterior leaflet <b>3004</b> of a mitral valve <b>3001</b>. Referring to <figref idref="DRAWINGS">FIGS. 31A-31B</figref>, an exemplary embodiment of a valve repair device <b>602</b> includes paddles <b>606</b> and gripping members <b>608</b>. In addition, the valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). Referring to <figref idref="DRAWINGS">FIG. 31A</figref>, the paddles <b>606</b> of the valve repair device <b>602</b> are pivoted outward in the direction X to create an opening <b>614</b> between the paddles <b>606</b> and the gripping members <b>608</b> having a width W. The width W can be, for example, between about 5 mm and about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about 10 mm. In alternative embodiments, the width W can be less than 5 mm or greater than 15 mm. Referring to <figref idref="DRAWINGS">FIG. 31B</figref>, the paddles <b>606</b> of the valve repair device <b>602</b> are moved outward in the direction Z such that the opening <b>614</b> has a width H. The width H can be, for example, between about 10 mm and about 25 mm, such as between about 10 mm and about 20 mm, such as between about 12.5 mm and about 17.5 mm, such as about 15 mm. In alternative embodiments, the width H can be less than 10 mm or more than 25 mm. In certain embodiments, the ratio between the width H and the width W can be about 5 to 1 or less, such as about 4 to 1 or less such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1 or less, such as about 1.25 to 1 or less, such as about 1 to 1. The valve repair device <b>602</b> can be configured such that the paddles <b>606</b> are pivoted outward in the direction X and then moved outward in the direction Z to create the opening <b>614</b> having a width H between the paddles <b>606</b> and the gripping members <b>608</b>. Alternatively, the valve repair device <b>602</b> can be configured such that the paddles are moved outward in the direction Z and then pivoted outward in the direction X to create width H between the paddles <b>606</b> and gripping members <b>608</b>. In addition, the valve repair device <b>602</b> can be configured such that the paddles <b>606</b> are pivoted outward in the direction X and moved outward in the direction Z simultaneously to create the width H between the paddles <b>606</b> and the gripping members <b>608</b>.
0156<figref idref="DRAWINGS">FIGS. 32A-32C</figref> illustrate a valve repair device <b>602</b> in which the paddles <b>606</b> are pivoted outward in the direction X, and, subsequently, moved outward in the direction Z to create a wider opening <b>614</b>. <figref idref="DRAWINGS">FIG. 32A</figref> illustrates the valve repair device <b>602</b> in a closed position, such that the paddles <b>606</b> are engaging the gripping members <b>608</b>. Referring to <figref idref="DRAWINGS">FIG. 32B</figref>, the paddles <b>606</b> are pivoted outward in the direction X to create an opening <b>614</b> having a width W for receiving valve tissue. Referring to <figref idref="DRAWINGS">FIG. 32C</figref>, after the paddles <b>606</b> are pivoted outward in the direction X, the paddles <b>606</b> are moved outward in the direction Z such that the opening <b>614</b> has a width H. After valve tissue is received in the openings <b>614</b> between the paddles <b>606</b> and the gripping members <b>608</b>, the valve repair device is moved back to the closed position (as shown in <figref idref="DRAWINGS">FIG. 32A</figref>) to secure the valve repair device <b>602</b> to the valve tissue. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0157<figref idref="DRAWINGS">FIGS. 33A-33C</figref> illustrate a valve repair device <b>602</b> in which the paddles <b>606</b> are moved outward in the direction Z, and, subsequently, pivoted outward in the direction X to create a wider opening <b>614</b>. <figref idref="DRAWINGS">FIG. 33A</figref> illustrates the valve repair device <b>602</b> in a closed position, such that the paddles <b>606</b> are engaging the gripping members <b>608</b>. Referring to <figref idref="DRAWINGS">FIG. 33B</figref>, the paddles <b>606</b> are moved outward in the direction Z to create an opening <b>614</b> having a width W for receiving valve tissue. Referring to <figref idref="DRAWINGS">FIG. 33C</figref>, after the paddles <b>606</b> are moved outward in the direction Z, the paddles <b>606</b> are pivoted outward in the direction X such that the opening <b>614</b> has a width H. After valve tissue is received in the openings <b>614</b> between the paddles <b>606</b> and the gripping members <b>608</b>, the valve repair device is moved back to the closed position (as shown in <figref idref="DRAWINGS">FIG. 33A</figref>) to secure the valve repair device <b>602</b> to the valve tissue. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0158While <figref idref="DRAWINGS">FIGS. 32A-32C</figref> illustrate a valve repair device <b>602</b> in which the paddles <b>606</b> are pivoted and then spread apart, and <figref idref="DRAWINGS">FIGS. 33A-33C</figref> illustrate a valve repair device <b>602</b> in which the paddles <b>606</b> are spread apart and then pivoted, it alternative embodiments, a valve repair device <b>602</b> can include paddles <b>606</b> that can be spread apart and pivoted simultaneously. In addition, in certain embodiments, the paddles <b>606</b> can be spread apart and pivoted independently of each other. That is, in the embodiments for the valve repair device <b>602</b> shown in <figref idref="DRAWINGS">FIGS. 32A-32C and 33A-33C</figref>, as well as the embodiment in which the spreading apart and pivoting of each paddle <b>606</b> is completed simultaneously, the paddles <b>606</b> can be controlled independently of each other.
0159Referring to <figref idref="DRAWINGS">FIGS. 34A-34B</figref>, another exemplary embodiment of a valve repair device <b>602</b> configured to close a wide gap <b>3002</b> (<figref idref="DRAWINGS">FIG. 30</figref>) between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> includes a W-shaped mechanism. In particular, the valve repair device <b>602</b> includes a coupler <b>605</b> configured to move along a shaft <b>603</b> and paddles <b>606</b> pivotally attached to the coupler <b>605</b>. The paddles <b>606</b> include an inner link <b>3402</b> and an outer link <b>3404</b>. The inner link <b>3402</b> of each paddle <b>606</b> is pivotally attached to coupler <b>605</b>, and the outer link <b>3404</b> of each paddle <b>606</b> is pivotally attached to the corresponding inner link <b>3402</b>. Referring to <figref idref="DRAWINGS">FIG. 34A</figref>, the valve repair device <b>602</b> is shown in a closed position. Referring to <figref idref="DRAWINGS">FIG. 34B</figref>, movement of the coupler <b>605</b> in the direction Y causes the inner links <b>3402</b> of the paddles <b>606</b> to extend in an outward direction X. In the illustrated example, the inner links <b>3402</b> engage a cam member <b>3403</b>, which forces the inner links <b>3402</b> to open in the X direction. Although the illustrated embodiment shows a valve repair device <b>602</b> having generally linear links <b>3402</b>, <b>3404</b> that create a W-shaped mechanism, it should be understood that the links <b>3402</b>, <b>3404</b> may take any suitable form that allows the valve repair device <b>602</b> to function as shown in <figref idref="DRAWINGS">FIGS. 34A-34B</figref>. In embodiments in which the links <b>3402</b>, <b>3404</b> take non-linear forms (e.g., a curved form), the valve repair device may not have a W-shaped mechanism, however, the valve repair device can include similar connections such that the valve repair device will function as shown in <figref idref="DRAWINGS">FIGS. 34A-34B</figref>.
0160The outer links <b>3404</b> can be moved to the illustrated more open position in the direction Z in a variety of different ways. For example, the outer links cam be moved using any of the clasp control arrangements described herein. For example, movement of the outer links <b>3404</b> can be controlled using any of the clasp control arrangements shown in <figref idref="DRAWINGS">FIGS. 22-26</figref> and/or any of the paddle control arrangements described herein. In one embodiment, referring to <figref idref="DRAWINGS">FIGS. 34C-34D</figref>, a link <b>3411</b> is attached to the pivotal connection between the inner link <b>3402</b> and the coupler <b>605</b> and the pivotal connection between the inner link <b>3402</b> and the outer link <b>3404</b>, such that movement of the coupler <b>605</b> in the direction Y causes a first end <b>3413</b> of the link <b>3411</b> to rotate in the direction M with the pivotal connection <b>3475</b>, which causes a second end <b>3415</b> of the link <b>3411</b> to rotate in the direction N with the pivotal connection <b>3477</b>. The rotation of the second end <b>3415</b> of the link <b>3411</b> in the direction N causes the outer link <b>3404</b> to move to an open position in the direction Z.
0161For illustrative purposes, the embodiment shown in <figref idref="DRAWINGS">FIGS. 34C-34D</figref> show a link <b>3411</b> for one of the paddles <b>606</b>, however, it should be understood that another link <b>3411</b> interacts with the other paddle in the same manner described above to cause the outer link <b>3404</b> of the other paddle to move to an open position in the direction Z. In an alternative embodiment, a four-bar linkage can be used to move the paddles <b>606</b> to an open position. In another alternative embodiment, a suture can be removably attached to the outer links <b>3404</b> of the paddles <b>606</b>, and the suture can be controlled to move the outer links <b>3404</b> of the paddles <b>606</b> to an open position in the direction Z.
0162In certain embodiments, the valve repair device <b>602</b> includes a biasing member <b>3410</b> (e.g., a spring) that attaches the inner links <b>3402</b> of the paddles <b>606</b> to each other. The biasing member <b>3410</b> maintains the inner links <b>3402</b> in a closed position (as shown in <figref idref="DRAWINGS">FIGS. 34A and 34C</figref>), until the inner links <b>3402</b> engage the cam member <b>3403</b> (as shown in <figref idref="DRAWINGS">FIGS. 34B and 34D</figref>). The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0163Referring to <figref idref="DRAWINGS">FIGS. 35A-35B</figref>, another exemplary embodiment of a valve repair device <b>602</b> configured to close a wide gap <b>3002</b> (<figref idref="DRAWINGS">FIG. 30</figref>) between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> includes a W-shaped mechanism. In particular, the valve repair device <b>602</b> includes a coupler <b>605</b> configured to be moved along a shaft <b>603</b> and paddles <b>606</b> pivotally attached to the shaft and to the coupler <b>605</b>. The lower ends <b>3501</b> of each paddle <b>606</b> of the valve repair device <b>602</b> are pivotally connected to the shaft at point A. Each of the paddles <b>606</b> include an intermediate member <b>3502</b> that pivotally attach the paddles to the coupler <b>605</b> at pivot point B. Referring to <figref idref="DRAWINGS">FIG. 35A</figref>, the valve repair device <b>602</b> is shown in a closed position. Referring to <figref idref="DRAWINGS">FIG. 35B</figref>, movement of the coupler <b>605</b> in the direction Y causes the intermediate members <b>3502</b> of the paddles <b>606</b> to pivot such that a lower end <b>3503</b> of the intermediate members <b>3502</b> extend in an outward direction X, which causes the paddles <b>606</b> to move to an open position in the direction Z. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0164Referring to <figref idref="DRAWINGS">FIGS. 36A-36B</figref>, another exemplary embodiment of a valve repair device <b>602</b> configured to close a wide gap <b>3002</b> (<figref idref="DRAWINGS">FIG. 30</figref>) between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> includes a W-shaped mechanism. In particular, the valve repair device <b>602</b> includes paddles <b>606</b> having a linkage <b>3602</b> pivotally attaching the paddles <b>606</b> to a shaft <b>603</b> of the valve repair device <b>602</b>. The linkage <b>3602</b> includes an inner link <b>3603</b> and an outer link <b>3605</b>. The inner link <b>3603</b> is pivotally attached to the shaft <b>603</b> and pivotally attached to the outer link <b>3605</b>. The outer link <b>3605</b> is pivotally attached to the inner link <b>3603</b> and pivotally attached to the paddle <b>606</b>. The paddles <b>606</b> are also attached to a link <b>3608</b> of the valve repair device <b>602</b>. A paddle control mechanism <b>610</b> is configured to move the pivotal connection at point A between the inner link <b>3603</b> and the outer link <b>3605</b> of the linkage <b>3602</b> in the direction Y, which causes the paddles <b>606</b> to move between an open position (as shown in <figref idref="DRAWINGS">FIG. 36B</figref>) and a closed position (as shown in <figref idref="DRAWINGS">FIG. 36A</figref>).
0165Still referring to <figref idref="DRAWINGS">FIGS. 36A and 36B</figref>, although the paddle control mechanism is shown attached at the pivotal connection point A, it should be understood that the paddle control mechanism <b>610</b> can be attached to one or more of any of the links of the valve repair device <b>602</b>. For example, the paddle control mechanism <b>610</b> can be coupled to the paddle <b>606</b>, the link <b>3605</b>, and/or the link <b>3603</b>. The paddle control mechanism <b>610</b> can take any suitable form, such as, for example, a control wire or any other form described in the present application. For example, the paddle control device <b>610</b> can take the form of any of the gripper control devices shown in <figref idref="DRAWINGS">FIGS. 6-8 and 22-26</figref>. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application.
0166Referring to <figref idref="DRAWINGS">FIG. 36C</figref>, the paddle control mechanism <b>610</b> of the embodiment illustrated by <figref idref="DRAWINGS">FIGS. 36A and 36B</figref> can include a spool <b>3620</b> and a line <b>3622</b> (e.g., a suture, a wire, etc.), and the line is attached to and wrapped around the spool. In this embodiment, creating a force on the line <b>3622</b> in the direction Z causes the spool <b>3620</b> to turn and line <b>3622</b> to be unwrapped from the spool. In this embodiment, the rotation of the spool <b>3620</b> causes the paddle control mechanism <b>610</b> to move in the direction Y and the valve repair device <b>602</b> to move to the open position (as shown in <figref idref="DRAWINGS">FIG. 36B</figref>).
0167Referring to <figref idref="DRAWINGS">FIGS. 36D-36E</figref>, another exemplary embodiment of a valve repair device <b>602</b> configured to close a wide gap <b>3002</b> (<figref idref="DRAWINGS">FIG. 30</figref>) between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> includes a semi-rigid W-shaped mechanism. In particular, the valve repair device <b>602</b> has a linkage <b>3602</b> that flexibly attaches the paddles <b>606</b> to a shaft <b>603</b> of the valve repair device <b>602</b>. The linkage <b>3602</b> includes a rigid inner link <b>3603</b> and an outer rigid link <b>3605</b>. The inner rigid link <b>3603</b> is flexibly attached to the shaft <b>603</b> by a flexible member or portion <b>3613</b> and flexibly attached to the outer rigid link <b>3605</b> by a flexible member or portion <b>3611</b>, and the outer rigid link <b>3506</b> is flexibly attached to the paddle <b>606</b> by a flexible member or portion <b>3615</b>. The paddles <b>606</b> are also flexibly attached to a link <b>3608</b> of the valve repair device <b>602</b> by a flexible member or portion <b>3617</b>. The rigid links <b>3603</b>, <b>3605</b> can be made of, for example, steel or nitinol. The flexible members <b>3611</b>, <b>3613</b>, <b>3615</b>, <b>3617</b> can be made of, for example, nitinol. A paddle control mechanism <b>610</b> is configured to move the pivotal connection at point A between the inner link <b>3603</b> and the outer link <b>3605</b> of the linkage <b>3602</b> in the direction Y, which causes the paddles <b>606</b> to move between an open position (as shown in <figref idref="DRAWINGS">FIG. 36D</figref>) and a closed position (as shown in <figref idref="DRAWINGS">FIG. 36C</figref>). However, the paddle control mechanism <b>610</b> can be attached to one or more of any of the links of the valve repair device. For example, the paddle control mechanism <b>610</b> can be coupled to the paddle <b>606</b>, the link <b>3605</b>, and/or the link <b>3603</b>. The paddle control mechanism <b>610</b> can take any suitable form, such as, for example, a control wire or any other form described in the present application. For example, the paddle control device <b>610</b> can take the form of any of the gripper control devices shown in <figref idref="DRAWINGS">FIGS. 6-8 and 22-26</figref>. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application.
0168Referring to <figref idref="DRAWINGS">FIGS. 37A-37D</figref>, another exemplary embodiment of a valve repair device <b>602</b> configured to close a wide gap <b>3002</b> (<figref idref="DRAWINGS">FIG. 30</figref>) between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> includes wire mesh paddles <b>606</b> and an internal cam <b>3702</b> configured to push the mesh paddles <b>606</b> apart. The internal cam <b>3702</b> is rotatably attached to the shaft <b>603</b> such that the cam can be moved between a first position (as shown in <figref idref="DRAWINGS">FIGS. 37A-37B</figref>) and a second position (as shown in <figref idref="DRAWINGS">FIGS. 37C-37D</figref>). <figref idref="DRAWINGS">FIG. 37B</figref> is a top view illustrating the internal cam <b>3702</b> in the first position, shown along the lines B-B in <figref idref="DRAWINGS">FIG. 37A</figref>. <figref idref="DRAWINGS">FIG. 37D</figref> is a top view illustrating the internal cam <b>3702</b> in the second position, shown along the lines D-D in <figref idref="DRAWINGS">FIG. 37C</figref>.
0169Referring to <figref idref="DRAWINGS">FIGS. 37A and 37B</figref>, when the internal cam <b>3702</b> is in the first position, the internal cam does not engage the paddles <b>606</b>, and the valve repair device is maintained in a closed position. Referring to <figref idref="DRAWINGS">FIGS. 37C and 37D</figref>, when the internal cam <b>3702</b> is in the second position, the internal cam engages the paddles <b>606</b> to move the paddles to move the paddles in an outward direction X to an open position. The valve repair device <b>602</b> is moved from the open position to the closed position by moving the internal cam <b>3702</b> from the second position to the first position.
0170In some embodiments, referring to <figref idref="DRAWINGS">FIGS. 37E-37F</figref>, the paddles <b>606</b> of the valve repair device can include a flexible member or portion <b>3711</b> that bias the paddles into the closed position or the open position. The flexible member or portion <b>3711</b> can be configured to flex upon being engaged by the cam <b>3702</b> to allow the paddles <b>606</b> to move to the open position. The flexible member or portion <b>3711</b> is also configured to widen the reach of the paddles <b>606</b> when the paddles are in the open position. Any other suitable mechanisms can be used to bias the paddles in the closed position and/or widen the reach of the paddles <b>606</b> when the paddles are in the open position, such as, for example, a spring-loaded mechanism. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The mesh paddles <b>606</b> can be made out of any suitable material that can be expanded by the internal cam <b>3702</b>, such as, for example, nitinol, stainless steel, or any braided or electrospun material.
0171Referring to <figref idref="DRAWINGS">FIGS. 38-39</figref>, in certain situations, the mitral valve <b>3001</b> of a patient can have a wide gap <b>3002</b> between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b> when the mitral valve is in a closed position (i.e., during the systolic phase). For example, the gap <b>3002</b> can have a width W between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, such as about 10 mm. In some situations, the gap <b>3002</b> can have a width W greater than 15 mm. In any of the above-mentioned situations, a valve repair device is desired that fills a sufficient volume to allow the gap <b>3002</b> to be closed or filled without placing a large amount of strain on the leaflets <b>3003</b>, <b>3004</b>. For example, the valve repair device can include a coaptation or spacer element <b>3800</b>.
0172Referring to <figref idref="DRAWINGS">FIG. 39</figref>, in certain embodiments, the coaptation or spacer element <b>3800</b> is attached to the valve repair device <b>602</b>, such that, when the paddles <b>606</b> and gripping members <b>608</b> secure the valve repair device <b>602</b> to the mitral valve <b>3001</b>, the coaptation or spacer element <b>3800</b> is disposed in the gap <b>3002</b> between the anterior leaflet <b>3003</b> and the posterior leaflet <b>3004</b>. The coaptation or spacer element <b>3800</b> can be made of any suitable material, such as, for example, braided mesh, fabric, biocompatible material, foam, pericardial tissue, any material disclosed herein, etc.
0173Referring to <figref idref="DRAWINGS">FIGS. 40A-40B</figref>, an exemplary embodiment of a valve repair device <b>602</b> has a coaptation or spacer element <b>3800</b> attached to the shaft <b>603</b> of the valve repair device. The spacer element <b>3800</b> can extend past the outer edges <b>4001</b> of the gripping members <b>3800</b> as illustrated for providing additional surface area for closing the gap <b>3002</b> (<figref idref="DRAWINGS">FIGS. 38-39</figref>) of a mitral valve <b>301</b>. In an alternative embodiment, the coupler member <b>605</b> can take the form of the spacer element <b>3800</b>. That is, a single element can be used as the coupler member <b>605</b> that causes the paddles <b>606</b> to move between the open and closed positions and the coaptation or spacer element <b>3800</b> that closes the gap between the leaflets <b>3003</b>, <b>3004</b> when the valve repair device <b>602</b> is attached to the leaflets. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0174Referring to <figref idref="DRAWINGS">FIGS. 42A-42C</figref>, the coaptation or spacer element <b>3800</b> shown in <figref idref="DRAWINGS">FIGS. 40A-40B</figref> can take a variety of different shapes. Referring to <figref idref="DRAWINGS">FIG. 42A</figref>, an exemplary embodiment of a spacer element <b>3800</b> includes a main body <b>4210</b><i>a </i>extending between the gripping members <b>608</b> and past the edges <b>4201</b> of the gripping members, and extended portions <b>4212</b><i>a </i>that extend from the main body <b>4210</b><i>a</i>. The extended portions <b>4212</b><i>a </i>allow portions of the gap <b>3002</b> (<figref idref="DRAWINGS">FIGS. 38-39</figref>) of the mitral valve between the anterior leaflet <b>3003</b> and posterior leaflet <b>3004</b> and adjacent to the valve repair device <b>602</b> to be filled when the valve repair device is in a closed position. That is, when a valve repair device <b>602</b> is attached to a mitral valve to prevent regurgitation of blood through the mitral valve, the portions of the mitral valve next to the valve repair device may include openings from the tissue of the mitral valve extending around the valve repair device. The extended portions <b>4212</b><i>a </i>are configured to fill or plug the openings adjacent to the valve repair device <b>602</b>. In the illustrated embodiment, the length L of the extended portions <b>4212</b><i>a </i>are greater than the width W of the extended portions.
0175Referring to <figref idref="DRAWINGS">FIG. 42B</figref>, another exemplary embodiment of a coaptation or spacer element <b>3800</b> includes a main body <b>4210</b><i>b </i>extending between the gripping members <b>608</b> and extended portions <b>4212</b><i>b </i>that extend from the main body <b>4210</b><i>b</i>. In the illustrated embodiment, the extended portions <b>4212</b><i>b </i>have a semicircular shape. The extended portions <b>4212</b><i>b </i>are configured to fill the openings adjacent to the valve repair device <b>602</b> due to tissue of the mitral valve extending around the valve repair device.
0176Referring to <figref idref="DRAWINGS">FIG. 42C</figref>, another exemplary embodiment of a spacer element <b>3800</b> includes a main base assembly <b>4210</b><i>c </i>extending between the gripping members <b>608</b>, first extending portions <b>4212</b><i>c </i>that extend from the main body <b>4210</b><i>c</i>, and second extending portions <b>4214</b><i>c </i>that extend from the first extending portions <b>4212</b><i>c</i>. In the illustrated embodiment, the first extended portions <b>4212</b><i>c </i>have a semicircular shape, and the second extended portions <b>4214</b><i>c </i>have a length L that is greater than its width W. The extended portions <b>4212</b><i>b </i>are configured to fill the openings adjacent to the valve repair device <b>602</b> due to tissue of the mitral valve extending around the valve repair device.
0177Referring to <figref idref="DRAWINGS">FIGS. 41A-41D</figref>, another exemplary embodiment of a valve repair device <b>602</b> has a coaptation or spacer element <b>3800</b> attached to the gripping members <b>608</b><i>a</i>, <b>608</b><i>b </i>of the valve repair device. The spacer element <b>3800</b> includes a first portion <b>4102</b> attached to one gripping member <b>608</b><i>a </i>and a second portion <b>4104</b> attached to the other gripping member <b>608</b><i>b</i>. Referring to <figref idref="DRAWINGS">FIG. 41C</figref>, the valve repair device <b>602</b> is shown in the closed position. When the valve repair device <b>602</b> is in the closed position, the first portion <b>4102</b> of the spacer element <b>3800</b> and the second portion <b>4104</b> of the spacer element <b>3800</b> engage each other and surround the shaft <b>603</b> (as shown in <figref idref="DRAWINGS">FIG. 41B</figref>). Referring to <figref idref="DRAWINGS">FIG. 41D</figref>, the valve repair device <b>602</b> is shown in the open position, the first portion <b>4102</b> of the spacer element <b>3800</b> moves with the gripping member <b>608</b><i>a</i>, and the second portion <b>4104</b> of the spacer element <b>3800</b> moves with the gripping member <b>608</b><i>b</i>. A coaptation or spacer element <b>3800</b> having multiple portions <b>4102</b>, <b>4104</b> allows the gripping members <b>608</b><i>a</i>, <b>608</b><i>b </i>to be moved to adjust the width of the opening between the paddles <b>606</b> and the gripping members, which is advantageous in attaching the valve repair device <b>602</b> to valve tissue <b>820</b>. Referring to <figref idref="DRAWINGS">FIG. 41B</figref>, the spacer element <b>3800</b> extends past the outer edges <b>4001</b> of the gripping members <b>3800</b> for providing additional surface area for filling the gap <b>3002</b> (<figref idref="DRAWINGS">FIGS. 38-39</figref>) of a mitral valve <b>301</b>. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0178Referring to <figref idref="DRAWINGS">FIGS. 43A-43C</figref>, the coaptation or spacer element <b>3800</b> shown in <figref idref="DRAWINGS">FIGS. 41A-41D</figref> can take a variety of different shapes. Referring to <figref idref="DRAWINGS">FIG. 43A</figref>, an exemplary embodiment of a spacer element <b>3800</b> in the closed position includes a main body <b>4310</b><i>a </i>extending between the gripping members <b>608</b> and past the edges <b>4201</b> of the gripping members, and extended portions <b>4312</b><i>a </i>that extend from the main body <b>4310</b><i>a</i>. The extended portions <b>4312</b><i>a </i>allow portions of the gap <b>3002</b> (<figref idref="DRAWINGS">FIGS. 38-39</figref>) of the mitral valve between the anterior leaflet <b>3003</b> and posterior leaflet <b>3004</b> and adjacent to the valve repair device <b>602</b> to be filled when the valve repair device is in a closed position. That is, when a valve repair device <b>602</b> is attached to a mitral valve to prevent regurgitation of blood through the mitral valve, the portions of the mitral valve next to the valve repair device may include openings from the tissue of the mitral valve extending around the valve repair device. The extended portions <b>4312</b><i>a </i>are configured to fill the openings adjacent to the valve repair device <b>602</b>. In the illustrated embodiment, the length L of the extended portions <b>4312</b><i>a </i>are greater than the width W of the extended portions.
0179Referring to <figref idref="DRAWINGS">FIG. 43B</figref>, another exemplary embodiment of a coaptation or spacer element <b>3800</b> in the closed position includes a main body <b>4310</b><i>b </i>extending between the gripping members <b>608</b> and extended portions <b>4312</b><i>b </i>that extend from the main body <b>4310</b><i>b</i>. In the illustrated embodiment, the extended portions <b>4312</b><i>b </i>have a semicircular shape. The extended portions <b>4312</b><i>b </i>are configured to fill the openings adjacent to the valve repair device <b>602</b> due to tissue of the mitral valve extending around the valve repair device.
0180Referring to <figref idref="DRAWINGS">FIG. 43C</figref>, another exemplary embodiment of a coaptation or spacer element <b>3800</b> includes a main base assembly <b>4310</b><i>c </i>extending between the gripping members <b>608</b>, first extending portions <b>4312</b><i>c </i>that extend from the main body <b>4310</b><i>c</i>, and second extending portions <b>4314</b><i>c </i>that extend from the first extending portions <b>4312</b><i>c</i>. In the illustrated embodiment, the first extended portions <b>4312</b><i>c </i>have a semicircular shape, and the second extended portions <b>4314</b><i>c </i>have a length L that is greater than its width W. The extended portions <b>4312</b><i>b </i>are configured to fill the openings adjacent to the valve repair device <b>602</b> due to tissue of the mitral valve extending around the valve repair device.
0181Referring to <figref idref="DRAWINGS">FIGS. 44A-44B</figref>, in certain embodiments, expanding gripping members <b>608</b> are integral with the valve repair device <b>602</b>. The expanding gripping members <b>608</b> are configured to expand as the paddles <b>606</b> close (as shown in <figref idref="DRAWINGS">FIG. 44B</figref>). Referring to <figref idref="DRAWINGS">FIG. 44A</figref>, the valve repair device <b>602</b> is in an open position such that valve tissue can be received in the opening <b>614</b> between the expanding gripping members <b>608</b> and the paddles <b>606</b>. Referring to <figref idref="DRAWINGS">FIG. 44B</figref>, the valve repair device <b>602</b> is in the closed position, in which the paddles <b>606</b> and the expanded gripper members <b>608</b> are engaged to secure the valve repair device to valve tissue. When the gripping members <b>608</b> and the paddles <b>606</b> are engaged, the gripping members <b>608</b> expand to provide a larger surface area for closing a gap <b>3002</b> (<figref idref="DRAWINGS">FIG. 38</figref>) between the anterior leaflet <b>3003</b> and posterior leaflet <b>3004</b> of a mitral valve <b>3001</b>. In the illustrated embodiment, the valve repair device <b>602</b> takes the form of the valve repair device <b>602</b> in <figref idref="DRAWINGS">FIGS. 35A-35B</figref>. However, any valve repair device <b>602</b> described in the present application can include expanding gripping members <b>608</b>. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0182Referring to <figref idref="DRAWINGS">FIGS. 45A-46D</figref>, in certain situations, the valve repair device <b>602</b> needs to be detached from a native valve and removed from the patient. In these situations, it is advantageous to have a valve repair device that can be narrowed and rearranged (to a bailout position) such that the valve repair device will be easier to remove from the patient without disturbing any valve tissue of the patient's heart. Referring to <figref idref="DRAWINGS">FIGS. 45A-45C</figref>, the base assembly <b>604</b> of an exemplary embodiment of a valve repair device <b>602</b> includes a first link <b>4521</b> extending from point A to point B, a second link <b>4522</b> extending from point A to point C, a third link <b>4523</b> extending from point B to point D, a fourth link <b>4524</b> extending from point C to point E, and a fifth link <b>4525</b> extending from point D to point E. A coupler <b>605</b> is movably attached to a shaft <b>603</b>, and the shaft <b>603</b> is fixed to the fifth link <b>4525</b>. The first link <b>4521</b> and the second link <b>4522</b> are pivotally attached to the coupler <b>605</b> at point A, such that movement of the coupler <b>605</b> along the shaft <b>603</b> moves the location of point A and, consequently, moves the first link <b>4521</b> and the second link <b>4522</b>. The first link <b>4521</b> and the third link <b>4523</b> are pivotally attached to each other at point B, and the second link <b>4522</b> and the fourth link <b>4524</b> are pivotally attached to each other at point C. One paddle <b>606</b><i>a </i>is attached to first link <b>4521</b> such that movement of first link <b>4521</b> causes the paddle <b>606</b><i>a </i>to move, and the other paddle <b>606</b><i>b </i>is attached to the second link <b>4522</b> such that movement of the second link <b>4522</b> causes the paddle <b>606</b><i>b </i>to move.
0183In order to move the valve repair device <b>602</b> from the closed position (as shown in <figref idref="DRAWINGS">FIG. 45A</figref>) to the bailout position (as shown in <figref idref="DRAWINGS">FIG. 45C</figref>), the coupler <b>605</b> is moved along the shaft <b>603</b> in the direction Y, which moves the pivot point A for the first link <b>4521</b> and the second link <b>4522</b> to a new position. Referring to <figref idref="DRAWINGS">FIG. 45A</figref>, the valve repair device <b>602</b> is shown in a closed position with an angle α between the paddle <b>606</b> and the shaft <b>603</b>. The angle α can be, for example, between about 0 degrees and about 45 degrees, such as between about 5 degrees and about 40 degrees, such as between about 15 degrees and about 30 degrees, such as between about 20 degrees and about 25 degrees. Referring to <figref idref="DRAWINGS">FIG. 45B</figref>, the valve repair device <b>602</b> is moved to the open position by moving the coupler <b>605</b> along the shaft <b>603</b> in the direction Y. Movement of the coupler <b>605</b> in the direction Y causes the first link <b>4521</b> to pivot about point A such that the first link <b>4521</b> and the second link <b>4522</b> move outward in the direction Z, which causes the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>to move downward and outward in the direction H. Referring to <figref idref="DRAWINGS">FIG. 45C</figref>, the valve repair device <b>602</b> is moved to the bailout position by continuing to move the coupler <b>605</b> along the shaft <b>603</b> in the direction Y. The continued movement of the coupler <b>605</b> in the direction Y causes the first link <b>4521</b> and the second link <b>4522</b> to move inward in the direction M, which causes the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>to move downward and inward in the direction N. Still referring to <figref idref="DRAWINGS">FIG. 45C</figref>, in the bailout position, the valve repair device <b>602</b> has an angle β between the paddles <b>606</b> and the shaft <b>603</b>. The angle β can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees.
0184Referring to <figref idref="DRAWINGS">FIGS. 46A-46D</figref>, the base assembly <b>604</b> of another exemplary embodiment of a valve repair device <b>602</b> includes a first link <b>4621</b> extending from point A to point B, a second link <b>4622</b> extending from point A to point C, a third link <b>4623</b> extending from point B to point D, a fourth link <b>4624</b> extending from point C to point E, a fifth link <b>4625</b> extending from point D to point F, and a sixth link <b>4626</b> extending from point E to point F. A coupler <b>605</b> is movably attached to a shaft <b>603</b>, and the shaft <b>603</b> is attached to the fifth link <b>4625</b> and the sixth link <b>4626</b> at point F. The first link <b>4621</b> and the second link <b>4622</b> are pivotally attached to the coupler <b>605</b> at point A, such that movement of the coupler <b>605</b> along the shaft <b>603</b> moves the location of point A and, consequently, moves the first link <b>4621</b> and the second link <b>4622</b>. The fifth link <b>4625</b> and the sixth link <b>4626</b> are pivotally attached to the shaft at point F, such that movement of the shaft moves the location of point F and, consequently, moves the fifth link <b>4625</b> and the sixth link <b>4626</b>. A locking element <b>4631</b> is configured to selectively lock the fifth link <b>4625</b> and the sixth link <b>4626</b> to the shaft at point F, such that the fifth link <b>4625</b> and the sixth link <b>4626</b> cannot pivot relative to the shaft <b>603</b> when the locking element <b>4631</b> is in the locked position. However, when the locking element <b>4631</b> is in the unlocked position, the fifth link <b>4625</b> and the sixth link <b>4626</b> can pivot about the shaft <b>603</b> when the shaft moves the location of point F (as described above). The first link <b>4621</b> and the third link <b>4623</b> are pivotally attached to each other at point B, and the second link <b>4622</b> and the fourth link <b>4624</b> are pivotally attached to each other at point C. One paddle <b>606</b><i>a </i>is attached to first link <b>4621</b> such that movement of first link <b>4621</b> causes the paddle <b>606</b><i>a </i>to move, and the other paddle <b>606</b><i>b </i>is attached to the second link <b>4622</b> such that movement of the second link <b>4622</b> causes the paddle <b>606</b><i>b </i>to move.
0185In order to move the valve repair device <b>602</b> from the closed position (as shown in <figref idref="DRAWINGS">FIG. 46A</figref>) to a bailout position (as shown in <figref idref="DRAWINGS">FIG. 46C</figref>), the locking element <b>4631</b> is maintained in a locked position, and the coupler <b>605</b> is moved along the shaft <b>603</b> in the direction Y, which moves the pivot point A for the first link <b>4621</b> and the second link <b>4622</b> to a new position. In order to move the valve repair device <b>602</b> from the bailout position to the collapsed bailout position (as shown in <figref idref="DRAWINGS">FIG. 46D</figref>), the locking element <b>4631</b> is moved to an unlocked position, and the shaft <b>603</b> is moved in the direction D, which moves the pivot point F for the fifth link <b>4625</b> and the sixth link <b>4626</b> to a new position, which causes the fifth link <b>4625</b> and the sixth link <b>4626</b> to pivot about the shaft <b>603</b>.
0186Referring to <figref idref="DRAWINGS">FIG. 46A</figref>, the valve repair device <b>602</b> is shown in a closed position with an angle α between the paddle <b>606</b> and the shaft <b>603</b>. The angle α can be, for example, between about 0 degrees and about 45 degrees, such as between about 5 degrees and about 40 degrees, such as between about 15 degrees and about 30 degrees, such as between about 20 degrees and about 25 degrees. Referring to <figref idref="DRAWINGS">FIG. 46B</figref>, the valve repair device <b>602</b> is moved to the open position by moving the coupler <b>605</b> along the shaft <b>603</b> in the direction Y. Movement of the coupler <b>605</b> in the direction Y causes the first link <b>4621</b> and the second link <b>4622</b> to move outward in the direction Z, which causes the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>to move downward and outward in the direction H. The locking element <b>4631</b> is maintained in the locked position when the valve repair device <b>602</b> is moved from the closed position (as shown in <figref idref="DRAWINGS">FIG. 46A</figref>) to the open position (as shown in <figref idref="DRAWINGS">FIG. 46B</figref>).
0187Referring to <figref idref="DRAWINGS">FIG. 46C</figref>, the valve repair device <b>602</b> is moved to the bailout position by continuing to move the coupler <b>605</b> along the shaft <b>603</b> in the direction Y. The continued movement of the coupler <b>605</b> in the direction Y causes the first link <b>4621</b> and the second link <b>4622</b> to move inward in the direction M, which causes the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>to move downward and inward in the direction N. Still referring to <figref idref="DRAWINGS">FIG. 45C</figref>, in the bailout position, the valve repair device <b>602</b> has an angle β between the paddles <b>606</b> and the shaft <b>603</b>. The angle β can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees. The locking element <b>4631</b> is maintained in the locked position when the valve repair device <b>602</b> is moved from the open position (as shown in <figref idref="DRAWINGS">FIG. 46B</figref>) to the bailout position (as shown in <figref idref="DRAWINGS">FIG. 46C</figref>).
0188Referring to <figref idref="DRAWINGS">FIG. 46D</figref>, the valve repair device <b>602</b> is moved from the bailout position to the collapsed position by moving the locking element <b>4631</b> to an unlocked position and moving the shaft <b>603</b> in the direction D, which causes the fifth link <b>4625</b> and the sixth link <b>4626</b> to pivot about connection point F and move upward in a direction J, which causes the third link <b>4623</b> and the fourth link <b>4624</b> to move inward and downward in the direction Q, which causes the paddles <b>606</b><i>a</i>, <b>606</b><i>b </i>to move downward and inward in the direction Q. Still referring to <figref idref="DRAWINGS">FIG. 46D</figref>, in the collapsed bailout position, the valve repair device <b>602</b> has an angle μ between the paddles <b>606</b> and the shaft <b>603</b>. The angle μ can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees, such as greater than or equal to 170 degrees.
0189It is advantageous to have a valve repair device that includes features to ensure that the valve repair device remains in a closed position after the valve repair device is attached to the native valve of a patient. In other words, it is advantageous to have a valve repair device that includes features to prevent the valve repair device from becoming detached from the native valve of a patient after placement of the valve repair device inside of the patient, which could cause problems (e.g., regurgitation of blood through the mitral valve). Examples of additional features for preventing a valve repair device from becoming detached from a native valve are shown in <figref idref="DRAWINGS">FIGS. 47A-49</figref>.
0190Referring to <figref idref="DRAWINGS">FIGS. 47A-47B</figref>, an exemplary embodiment of a valve repair device <b>602</b> includes a latch member <b>4701</b> attached to the paddles <b>606</b>, in which the latch member <b>4701</b> is configured to attach the paddles <b>606</b> to the gripping members <b>608</b> when the valve repair device is in the closed position. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). In the illustrated embodiment, the valve repair device <b>602</b> includes an optional lock <b>607</b> configured to keep a coupler <b>605</b> in a locked condition on the shaft <b>603</b>. If the optional lock <b>607</b> fails, however, the coupler <b>605</b> could move on the shaft <b>603</b> and cause the valve repair device to move to an open position. The latch member <b>4701</b> is configured to keep the valve repair device <b>602</b> in the closed position if the lock <b>607</b> fails.
0191Referring to <figref idref="DRAWINGS">FIG. 47A</figref>, the valve repair device <b>602</b> is in an open position with valve tissue <b>820</b> disposed in the opening <b>614</b> between the paddles <b>606</b> and the gripping members <b>608</b>. Referring to <figref idref="DRAWINGS">FIG. 47B</figref>, the valve repair device <b>602</b> is moved to the closed position such that the valve tissue <b>820</b> is secured between the paddles <b>606</b> and the gripping members <b>608</b> of the valve repair device. The valve repair device <b>602</b> can be moved to the closed position by any suitable manner, such as, for example, any manner described in the present application. When the valve repair device <b>602</b> is moved to the closed position, the latch member <b>4701</b> punctures the valve tissue <b>820</b> and the gripping member <b>608</b> to secure the paddle to the gripping member. The latch member <b>4701</b> can take any suitable form that is capable of securing the paddles <b>606</b> to the gripping members <b>608</b>, such as, for example, metals, plastics, etc.
0192Referring to <figref idref="DRAWINGS">FIG. 48</figref>, another exemplary embodiment of a valve repair system <b>600</b> includes a delivery device <b>601</b> and a valve repair device <b>602</b>, in which is delivery device is configured to deliver the valve repair device to the native valve of a patient, and in which the valve repair device is configured to attach to leaflets of a native valve to repair the native valve of the patient. The delivery device <b>601</b> can take any suitable form that is capable of delivering the valve repair device <b>602</b> to the native valve of a patient, such as, for example, any form described in the present application. The valve repair device <b>602</b> includes a base assembly <b>604</b>, a pair of paddles <b>606</b>, and a pair of gripping members <b>608</b>. The base assembly <b>604</b> of the valve repair device <b>602</b> has a shaft <b>603</b> and a coupler <b>605</b> configured to move along the shaft. The coupler <b>605</b> is mechanically connected to the paddles such that movement of the coupler along the shaft <b>603</b> causes the paddles to move between an open position and a closed position. In the closed position, the paddles <b>606</b> and the gripping members <b>608</b> engage valve tissue and each other to secure the valve repair device <b>602</b> to the valve tissue. The valve repair device <b>602</b> also includes a biasing member <b>4807</b> (e.g., a spring) configured to bias the coupler <b>605</b> on the shaft such that the valve repair device <b>602</b> is in a closed position.
0193In certain embodiments, the valve repair system <b>600</b> includes a placement shaft <b>613</b> that is removably attached to the shaft <b>603</b> of the base assembly <b>604</b> of the valve repair device <b>602</b>. After the valve repair device <b>602</b> is secured to valve tissue, the placement shaft <b>613</b> is removed from the shaft <b>603</b> to remove the valve repair device <b>602</b> from the valve repair system <b>600</b>, such that the valve repair device <b>602</b> can remain attached to the valve tissue, and the delivery device <b>601</b> can be removed from a patient's body. After the valve repair device <b>602</b> is attached to the valve tissue, and the valve repair system <b>600</b> is removed from the patient's body, the biasing member <b>4807</b> maintains the valve repair device in a closed position to prevent detachment of the valve repair device from the valve tissue. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0194Referring to <figref idref="DRAWINGS">FIG. 49</figref>, another exemplary embodiment of a valve repair system <b>600</b> includes a delivery device <b>601</b> and a valve repair device <b>602</b>, in which the delivery device is configured to deliver the valve repair device to the native valve of a patient, and in which the valve repair device is configured to attach to leaflets of a native valve to repair the native valve of the patient. The delivery device <b>601</b> can take any suitable form that is capable of delivering the valve repair device <b>602</b> to the native valve of a patient, such as, for example, any form described in the present application. The valve repair device <b>602</b> includes a base assembly <b>604</b>, a pair of paddles <b>606</b>, and a pair of gripping members <b>608</b>. The base assembly <b>604</b> of the valve repair device <b>602</b> has a shaft <b>603</b> and a coupler <b>605</b> configured to move along the shaft. In the illustrated embodiment, the shaft <b>603</b> includes a threaded portion <b>4902</b>, and the coupler <b>605</b> is configured to move along the threaded portion <b>4902</b> of the shaft. That is, rotating the shaft <b>603</b> causes the coupler <b>605</b> to move up and down the shaft <b>603</b>. The coupler <b>605</b> is mechanically connected to the paddles such that movement of the coupler along the shaft <b>603</b> causes the paddles to move between an open position and a closed position. In the closed position, the paddles <b>606</b> and the gripping members <b>608</b> engage valve tissue and each other to secure the valve repair device <b>602</b> to the valve tissue.
0195In certain embodiments, the valve repair system <b>600</b> includes a placement shaft <b>613</b> that is removably attached to the shaft <b>603</b> of the base assembly <b>604</b> of the valve repair device <b>602</b>. After the valve repair device <b>602</b> is secured to valve tissue, the placement shaft <b>613</b> is removed from the shaft <b>603</b> to remove the valve repair device <b>602</b> from the valve repair system <b>600</b>, such that the valve repair device <b>602</b> can remain attached to the valve tissue, and the delivery device <b>601</b> can be removed from a patient's body. After the valve repair device <b>602</b> is attached to the valve tissue, and the valve repair system <b>600</b> is removed from the patient's body, the valve repair device is prevented from detaching from the valve tissue, because the coupler can only be moved by rotating the shaft <b>603</b>. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0196Referring to <figref idref="DRAWINGS">FIGS. 50-54</figref>, embodiments of valve repair systems <b>600</b> include a delivery device <b>601</b> and a valve repair device <b>602</b>, in which the delivery device is configured to deliver the valve repair device to the native valve of a patient, and in which the valve repair device is configured to attach to leaflets of a native valve to repair the native valve of the patient. The delivery device <b>601</b> can take any suitable form that is capable of delivering the valve repair device <b>602</b> to the native valve of a patient, such as, for example, any form described in the present application. The valve repair device <b>602</b> is similar to the valve repair devices described above and includes a base assembly <b>604</b>, a pair of paddles <b>606</b>, and a pair of gripping members <b>608</b>. The base assembly <b>604</b> of the valve repair device <b>602</b> has a shaft <b>603</b> and a coupler <b>605</b> configured to move along the shaft. The coupler <b>605</b> is mechanically connected to the paddles such that movement of the coupler along the shaft <b>603</b> causes the paddles to move between an open position and a closed position. In some embodiments, the valve repair device <b>602</b> includes a lock <b>607</b> configured to lock the coupler <b>605</b> in a desired position on the shaft (as shown in <figref idref="DRAWINGS">FIGS. 50-53B</figref>). In alternative embodiments, the valve repair device <b>602</b> includes a biasing member <b>4807</b> configured to maintain the coupler <b>605</b> in a desired position on the shaft <b>603</b> (as shown in <figref idref="DRAWINGS">FIG. 54</figref>). In the closed position, the paddles <b>606</b> and the gripping members <b>608</b> engage valve tissue and each other to secure the valve repair device <b>602</b> to the valve tissue. In certain embodiments, the valve repair system <b>600</b> includes a placement shaft <b>613</b> that is removably attached to the shaft <b>603</b> of the base assembly <b>604</b> of the valve repair device <b>602</b>. After the valve repair device <b>602</b> is secured to valve tissue, the placement shaft <b>613</b> is removed from the shaft <b>603</b> to remove the valve repair device <b>602</b> from the valve repair system <b>600</b>, such that the valve repair device <b>602</b> can remain attached to the valve tissue, and the delivery device <b>601</b> can be removed from a patient's body. The valve repair device <b>602</b> can include any other features for a valve repair device discussed in the present application, and the valve repair device <b>602</b> can be positioned to engage valve tissue <b>820</b> as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).
0197Referring to <figref idref="DRAWINGS">FIG. 50</figref>, in some embodiments, the gripping members <b>608</b> are attached to the paddles <b>606</b>. In the example illustrated by <figref idref="DRAWINGS">FIG. 50</figref>, the gripping members <b>608</b> include an attachment portion <b>5010</b>, a hinge or flex portion <b>5012</b>, and a gripping or barbed portion <b>5014</b>. The attachment portion <b>5010</b> can take any form that allows the gripping member to be attached to the paddle <b>606</b>. The hinge or flex portion <b>5012</b> can take a variety of different forms. For example, the hinge or flex portion can be configured to bias the gripping or barbed portion <b>5014</b> toward the attachment portion <b>5010</b>. In one exemplary embodiment, the hinge or flex portion <b>5012</b> biases the gripping or barbed portion <b>5014</b> to a fully closed position where the gripping or barbed portion engages the attachment portion <b>5010</b> and/or the paddle <b>606</b>. When valve tissue is positioned between the paddle <b>606</b> and the gripping portion <b>5014</b>, the hinge or flex portion biases the gripping portion <b>5014</b> to clamp the valve tissue between the gripping or barbed portion <b>5014</b> and the paddle. The gripping member <b>608</b> illustrated by <figref idref="DRAWINGS">FIG. 50</figref> moves with the paddle <b>606</b>. The hinge or flex portion <b>5012</b> allows the gripping portion <b>5014</b> to move in the direction indicated by arrows <b>5020</b> and can allow the gripping portion to be pulled in the direction indicated by arrows <b>5022</b>.
0198In certain embodiments, it is advantageous for the barbed portion <b>609</b> to be disposed toward a proximal end of the gripping members <b>608</b> because it will provide for an easier release of the gripping members <b>608</b> from valve tissue. Referring to <figref idref="DRAWINGS">FIG. 51</figref>, in one embodiment, the gripping members <b>608</b> comprise a single row of barbs <b>5102</b> configured to engage the valve tissue and the paddles <b>606</b> to secure the valve repair device to the valve tissue. The single row of barbs <b>5102</b> makes it easier for the gripping portion <b>5014</b> to release from the valve tissue. In an alternative embodiment, the gripping members <b>608</b> can comprise two or more rows of barbs <b>5102</b> disposed at a proximal end of the gripping members <b>608</b>. In additional embodiments, the barbs <b>5102</b> can be disposed at a proximal end of the gripping members <b>608</b> in any other suitable configuration that provides for an easier release of the gripping members <b>608</b> from valve tissue.
0199In some embodiments, as shown in <figref idref="DRAWINGS">FIGS. 51A-51E</figref>, the gripping member <b>608</b> is configured to place a tensioning force on the valve tissue when the valve repair device (e.g., any valve repair device <b>602</b> described in the present application) is attached to the valve tissue. The gripping member <b>608</b> is slidably connected to the paddle <b>606</b>, such that the gripping member <b>608</b> can be moved along the paddle in the direction X. For example, a gripper control mechanism <b>611</b> can be used to move the gripping member <b>608</b> along the paddle <b>606</b> in the direction X, and the gripper control mechanism <b>611</b> can also be used to move the gripping member <b>608</b> between the closed position (as shown in <figref idref="DRAWINGS">FIG. 51A</figref>) and the open position (as shown in <figref idref="DRAWINGS">FIG. 51B</figref>). The gripper control mechanism <b>611</b> can take any form described in the present application. In certain embodiments, the valve repair device <b>602</b> includes an optional biasing member <b>5122</b> (e.g., a spring) configured to maintain the gripping member <b>608</b> in a desired position along the paddle <b>606</b> (e.g., the position shown in <figref idref="DRAWINGS">FIGS. 51A and 51E</figref>). In the illustrated embodiment, the gripping member <b>608</b> includes a single row of barbs <b>609</b> at a proximal end of the gripping members (e.g. as shown in the embodiment of the valve repair device <b>602</b> shown in <figref idref="DRAWINGS">FIG. 51</figref>), however, it should be understood that the features described herein regarding <figref idref="DRAWINGS">FIGS. 51A-51E</figref> can be used with any of the embodiments of the valve repair device described in the present application.
0200Referring to <figref idref="DRAWINGS">FIG. 51A</figref>, the gripping member <b>608</b> is shown in a first position on the paddle <b>606</b> and in a closed position. Referring to <figref idref="DRAWINGS">FIG. 51B</figref>, the gripping member <b>608</b> is shown after it has been moved in the direction Z to an open position by the gripper control mechanism <b>611</b>. Referring to <figref idref="DRAWINGS">FIG. 51C</figref>, the gripping member <b>608</b> is shown after it has been moved along the paddle <b>606</b> in the direction D to a second position. In certain embodiments, the gripping member <b>608</b> is moved along the paddle in the direction D by the gripper control mechanism <b>611</b> or a separate mechanism. In embodiments that include the biasing member <b>5122</b>, enough force needs to be applied on the gripping member <b>608</b> to move the gripping member in the direction D, which will cause the biasing member to expand and create a tensioning force on the gripping member <b>608</b> in the direction B. While the illustrated embodiment shows the gripping member <b>608</b> being moved to an open position (as shown in <figref idref="DRAWINGS">FIG. 51B</figref>) prior to the gripping member <b>608</b> being moved along the paddle <b>606</b> in the direction D to the second position (as shown in <figref idref="DRAWINGS">FIG. 51C</figref>), it should be understood that gripping member <b>608</b> can be moved in the direction D to the second position prior to the gripping member <b>608</b> being moved in the direction Z to an open position or the movements can be simultaneous. Referring to <figref idref="DRAWINGS">FIG. 51D</figref>, the gripping member <b>608</b> is moved to a closed position in the direction Y by the gripper control mechanism <b>611</b> to secure the barbed portion <b>609</b> of the gripping member <b>608</b> to valve tissue (not shown). In the position shown in <figref idref="DRAWINGS">FIG. 51D</figref>, the biasing member <b>5122</b> is being maintained in an extended position (e.g., as a result of the force applied to the gripping member <b>608</b> by the gripper control mechanism (or another mechanism) to keep the gripping member in the second position), which means the biasing member <b>5122</b> is placing a tensioning force on the gripping member <b>608</b> in the direction B. Referring to <figref idref="DRAWINGS">FIG. 51E</figref>, after the barbed portion <b>609</b> of the gripping member <b>608</b> is secured to the valve tissue, the force maintaining the gripping member <b>608</b> in the second position is released, which causes the tensioning force applied by the biasing member <b>5122</b> to move the gripping member <b>608</b> along the paddle <b>606</b> in the direction M. The movement of the gripping member <b>608</b> in the direction M causes the barbed portion <b>609</b> to create a tensioning force on the valve tissue in the direction T. This tensioning force on the valve tissue allows the valve repair device <b>602</b> to maintain a secure connection to the valve tissue.
0201In another embodiment, as shown in <figref idref="DRAWINGS">FIGS. 51F-51G</figref>, the gripping member <b>608</b> includes a barbed portion <b>609</b> and a weakened or flexing portion <b>5103</b>. The barbed portion <b>609</b> is disposed on a first side <b>5111</b> of the weakened or flexing portion <b>5103</b>. In the illustrated embodiment, the barbed portion <b>609</b> includes a single row of barbs, but it should be understood that any suitable configuration of the barbs can be used, such as, for example, any configuration described in the present application. The weakened portion or flexing <b>5103</b> can be, for example, a cutout in the gripping member, a different material as compared to the remainder of the gripping member <b>608</b>, or can take any other suitable form that allows the weakened or flexing portion <b>5103</b> to be weaker and/or more flexible than a remained of the gripping member <b>608</b>. However, in other embodiments, the weaker and flexible portion <b>5103</b> is omitted and the link <b>5107</b> and line <b>5105</b> described below are still able to flex the barbed portion as illustrated by <figref idref="DRAWINGS">FIGS. 51F-51H</figref>.
0202Referring to <figref idref="DRAWINGS">FIGS. 51F-51H</figref>, the gripper control mechanism <b>611</b> includes a line <b>5105</b> (e.g., a suture) and a push/pull link <b>5107</b> configured to receive the line <b>5105</b>. For example, the push/pull link <b>5107</b> can be a catheter, a wire with a loop (as shown <figref idref="DRAWINGS">FIG. 25A</figref>), or any other link that is capable of receiving the line <b>5105</b> and pushing/pulling the gripping member <b>608</b>. A first end <b>5125</b> of the line <b>5105</b> extends from a delivery device (e.g., any delivery device <b>601</b> described in the present application) and is removably attached to the gripping member <b>608</b> on a first side <b>5111</b> of the weakened or flexible portion <b>5103</b> at a first connection point A. The line <b>5105</b> also extends from the connection point A and is removably attached to the gripping member <b>608</b> on a second side <b>5113</b> of the weakened or flexible portion <b>5103</b> at a second connection point B. In addition, the line <b>5105</b> extends from the second connection point B and through push/pull link <b>5107</b>.
0203Referring to <figref idref="DRAWINGS">FIG. 51F</figref>, the gripping member <b>608</b> is shown in an open position with a valve tissue member <b>820</b> disposed in an opening <b>614</b> between the gripping member <b>608</b> and a paddle (not shown). The gripping member can be moved to the open position by pulling on the line <b>5105</b>. Referring to <figref idref="DRAWINGS">FIG. 51G</figref>, the link <b>5107</b> and line <b>5105</b> of the gripper control mechanism <b>611</b> is used to move the gripping member <b>608</b> in the direction X to the closed position and flex the portion <b>609</b> in the direction Y. The first end <b>5125</b> of the line <b>5105</b> is pulled in a direction Y, such that the first side <b>5111</b> of the gripping member <b>608</b> pivots or flexes about the weakened portion <b>5103</b>. This flexing causes the barbed portion <b>609</b> to move in directions U and Y to a flexed position. Still referring to <figref idref="DRAWINGS">FIG. 51G</figref>, the link <b>5107</b> and the line <b>5105</b> are moved such that the barbed portion <b>609</b> pierces the valve tissue <b>820</b> while the barbed portion is in the flexed position.
0204Referring to <figref idref="DRAWINGS">FIG. 51H</figref>, the line <b>5105</b> is released, which causes the first end <b>5111</b> of the gripping member <b>608</b> to pivot about the weakened or flexible portion <b>5103</b>. This causes the barbed portion <b>609</b> to move through the valve tissue <b>820</b> in a direction D, which causes the barbed portion <b>609</b> the valve repair device to create a tensioning force on the valve tissue <b>820</b> in the direction D. After the gripping member <b>608</b> is secured to the valve tissue <b>820</b> (as shown in <figref idref="DRAWINGS">FIG. 51H</figref>), the link <b>5107</b> and the line <b>5105</b> are removed from the gripping member <b>608</b>.
0205Referring to <figref idref="DRAWINGS">FIG. 52</figref>, in various embodiments, the gripping members <b>608</b> include a stretchable portion <b>5202</b> to allow for movement in the direction <b>5204</b>. The movement in the direction <b>5204</b> allows for clean disengagement from the valve tissue. In some embodiments, the stretchable portion <b>5202</b> is configured to be moved such that the barbs <b>5102</b> exit the valve tissue in a direction substantially opposite the direction in which the barbs entered the valve tissue. Alternatively, the gripping members <b>608</b> can be otherwise extendable to allow for disengagement from the valve tissue without tearing the valve tissue. For example, as mentioned above, the hinge portions <b>5012</b> can be configured to allow the gripping portions <b>5014</b> of the gripping members <b>608</b> to be pulled in the direction <b>5204</b>.
0206Referring to <figref idref="DRAWINGS">FIGS. 53A-53B</figref>, in certain embodiments, the gripping members <b>608</b> are made of flexible material. Referring to <figref idref="DRAWINGS">FIG. 53A</figref>, the valve repair device <b>602</b> is shown in a closed position and secured to valve tissue <b>820</b>. Referring to <figref idref="DRAWINGS">FIG. 53B</figref>, the gripping members <b>608</b> are shown being moved by the gripper control mechanism <b>611</b> to remove the gripping members <b>608</b> from the valve tissue <b>820</b>. In particular, movement of the gripper control mechanism <b>611</b> in the direction Y causes the gripping members <b>608</b> to peel back off of the valve tissue in the direction Z. The flexible material of the gripping members <b>608</b> allows for the peeling back of the gripping members <b>608</b> when removing the gripping members from the valve tissue <b>820</b>. The peeling back of the gripping members <b>608</b> is advantageous because it helps the gripping members to pull out of the valve tissue <b>820</b> without damaging the valve tissue. In certain embodiments, the flexible gripping members <b>608</b> allows for the barbed portion <b>609</b> of the gripping members <b>608</b> to be removed from valve tissue in a direction substantially opposite the direction in which the barbs entered the valve tissue.
0207Referring to <figref idref="DRAWINGS">FIG. 54</figref>, in certain embodiments, the gripping members <b>608</b> are connected to each other by a separate biasing member <b>5410</b> (e.g., a spring) that is configured to maintain the gripping members in a desired position, such that, when the paddles <b>606</b> are in an open position, a width W exists between the paddles and the gripping members. The width W can be adjusted by engaging the gripping members <b>608</b> with the gripper control mechanism <b>611</b>. That is, movement of the gripper control mechanism <b>611</b> into the delivery device in the direction Z will cause the biasing member <b>5410</b> to flex and the paddles to move in an inward direction X. Disengagement of the gripping members by the gripper control mechanism <b>611</b> will cause the biasing member <b>5410</b> to move the desired position (as shown in <figref idref="DRAWINGS">FIG. 54</figref>). The gripper control mechanism <b>611</b> can take any suitable form for controlling the gripping members <b>608</b>, such as, for example, any form described in the present application. In addition, when the paddles <b>606</b> are moved to the closed position, the paddles will engage the gripping members <b>608</b>, which will cause the biasing member to flex and the gripping members to move in an inward direction X. The paddles <b>608</b> can be moved from the open position to the closed position in any suitable manner, such as, for example, any manner described in the present application. While the various devices described in the present application refer to engaging and repairing the mitral valve, it should be understood that these devices can be used in repairing any other native valves (e.g., the tricuspid valve, the pulmonary valve, the aortic valve) or any other portion of the heart. In addition, it should be understood that various features of the various embodiments for the devices described herein can be used in combination with each other.
0208While the foregoing is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents can be used. Moreover, it will be obvious that certain other modifications can be practiced within the scope of the appended claims.
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4 members in 2 offices; this record represents the family
Priority claims2
| Document | Office | Kind | Date |
|---|---|---|---|
| 201815865904 | United States of America | A | |
| US201815865904 | – | – | – |
Members4
| Document | Office | Kind | |
|---|---|---|---|
| US10076415B1This record | United States of America | B1 | |
| US2019209294A1 | United States of America | A1 | |
| WO2019139643A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US10959847B2 | United States of America | B2 |
70 transactions on the USPTO file
Allowed without a rejection on record.
- Non-final rejections
- 0
- Final rejections
- 0
- RCEs
- 0
- Appeals
- 0
Over time
Point at a mark for the transactionTransactions
| Event | Code | |
|---|---|---|
| Payment of Maintenance Fee, 8th Year, Large EntityM1552 | M1552 | |
| Payment of Maintenance Fee, 4th Year, Large EntityM1551 | M1551 | |
| Email NotificationEML_NTR | EML_NTR | |
| Change in Power of Attorney (May Include Associate POA)PA.. | PA.. | |
| Correspondence Address ChangeC.AD | C.AD | |
| Recordation of Patent Grant MailedPGM/ | PGM/ | |
| Application ready for PDX access by participating foreign officesCCRDY | CCRDY | |
| Patent Issue Date Used in PTA CalculationAllowedPTAC | PTAC | |
| Email NotificationEML_NTR | EML_NTR | |
| Issue Notification MailedAllowedWPIR | WPIR | |
| Email NotificationEML_NTR | EML_NTR | |
| Printer Rush- No mailingTCPB | TCPB | |
| Mail Response to 312 Amendment (PTO-271)MN271 | MN271 | |
| Dispatch to FDCD1935 | D1935 | |
| Application Is Considered Ready for IssuePILS | PILS | |
| Response to Amendment under Rule 312N271 | N271 | |
| Issue Fee Payment VerifiedN084 | N084 | |
| Issue Fee Payment ReceivedIFEE | IFEE | |
| Email NotificationEML_NTR | EML_NTR | |
| Filing Receipt - CorrectedFLRCPT.C | FLRCPT.C | |
| Miscellaneous Incoming LetterLET. | LET. | |
| Pubs Case Remand to TCPUBTC | PUBTC | |
| Amendment after Notice of Allowance (Rule 312)AllowedA.NA | A.NA | |
| Workflow - Drawings FinishedDRWF | DRWF | |
| Email NotificationEML_NTR | EML_NTR | |
| Printer Rush- No mailingTCPB | TCPB | |
| Mailing Corrected Notice of AllowabilityMCNOA | MCNOA | |
| Reasons for AllowanceEX.R | EX.R | |
| Examiner's Amendment CommunicationEX.A | EX.A | |
| Corrected Notice of AllowabilityCNOA | CNOA | |
| Pubs Case Remand to TCPUBTC | PUBTC | |
| Electronic ReviewELC_RVW | ELC_RVW | |
| Email NotificationEML_NTF | EML_NTF | |
| Mail Notice of AllowanceAllowedMN/=. | MN/=. | |
| Notice of Allowance Data Verification CompletedAllowedN/=. | N/=. | |
| Interview Summary - Examiner Initiated - TelephonicEXET | EXET | |
| Reasons for AllowanceEX.R | EX.R | |
| Examiner's Amendment CommunicationEX.A | EX.A | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Track 1 Request GrantedT1GR | T1GR | |
| Mail O.P. Petition DecisionMOPPT | MOPPT | |
| Application Dispatched from OIPEOIPE | OIPE | |
| Track 1 Request GrantedT1GR | T1GR | |
| Mail-Record Petition Decision of Granted to Make SpecialMP003 | MP003 | |
| Record Petition Decision of Granted to Make SpecialP003 | P003 | |
| O.P. Petition DecisionOPPT | OPPT | |
| Email NotificationEML_NTR | EML_NTR | |
| Application Is Now CompleteCOMP | COMP | |
| Filing Receipt - UpdatedFLRCPT.U | FLRCPT.U | |
| Sent to Classification ContractorPGPC | PGPC | |
| FITF set to YES - revise initial settingFTFS | FTFS | |
| Patent Term Adjustment - Ready for ExaminationPTA.RFE | PTA.RFE | |
| Additional Application Filing FeesADDFLFEE | ADDFLFEE | |
| Electronic ReviewELC_RVW | ELC_RVW | |
| Email NotificationEML_NTR | EML_NTR | |
| Email NotificationEML_NTF | EML_NTF | |
| Notice Mailed--Application Incomplete--Filing Date AssignedINCD | INCD | |
| Filing ReceiptFLRCPT.O | FLRCPT.O | |
| Cleared by L&R (LARS)L128 | L128 | |
| Referred to Level 2 (LARS) by OIPE CSRL198 | L198 | |
| PTO/SB/69-Authorize EPO Access to Search ResultsSREXR141 | SREXR141 | |
| Applicants have given acceptable permission for participating foreignAPPERMS | APPERMS | |
| Track 1 RequestTK1R | TK1R | |
| Petition EnteredPET. | PET. | |
| IFW Scan & PACR Auto Security ReviewSCAN | SCAN | |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change)BIG. | BIG. | |
| Initial Exam Team nnIEXX | IEXX |
4 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Maintenance fee paymentMAFP | MAFP | |
| Maintenance fee paymentMAFP | MAFP | |
| Information on status: patent grantGrantedPATENTED CASESTCF | STCF | |
| Fee payment procedureENTITY STATUS SET TO UNDISCOUNTED (ORIGINAL EVENT CODE: BIG.); ENTITY STATUS OF PATENT OWNER: LARGE ENTITYFEPP | FEPP |
Numbers
- Publication
- 10076415
- Publication, DOCDB
- 10076415
- Publication, EPODOC
- US10076415
- Application
- 15865904
- Application, DOCDB
- 201815865904
- Application, EPODOC
- US201815865904
Titles
- English
- Native valve repair devices and procedures
Patent term adjustment
- Applicant delay
- −12 days
- Net adjustment
- 0 days
Classification
- CPC, 6
- A61F2/246
- A61F2/2466
- A61F2220/0016
- A61F2220/0025
- A61F2230/0013
- A61F2230/0045
- IPC, 1
- A61F2 24
- USPC, 1
- 606207000